[(NOTIFICATION LETTER)]{.underline} (USER)

(NOTIFICATION TO USER/NONCOMPLIANCE AS THE RESULT OF FIELD TESTING)

[CERTIFIED MAIL]{.underline}-[RETURN RECEIPT REQUESTED]{.underline}

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM\'S COMPLETE ADDRESS

Dear [(addressee)]{.underline} :

On [(date)]{.underline} , a field test was performed on the [(name of
mfr.)]{.underline} diagnostic x-ray system, control model number ,
located in room of your facility. We tested this system to determine its
compliance with portions of the Performance Standard for Diagnostic
X-ray Equipment (Title 21, [Code of Federal Regulations]{.underline}
(CFR), sections 1020.30‑32).

Analysis of the data obtained from the field test shows the system fails
to comply with the following requirements of the Federal performance
standard for diagnostic x-ray systems:

**(Describe Each Item of Noncompliance)**

Our investigation indicates that neither the manufacturer nor the
assembler is likely to be responsible for these noncompliances under the
regulations. The use of a noncompliant x-ray system may result in
unnecessary radiation exposure to the patient or operator. Therefore, we
encourage you to arrange for correction of the noncompliance.

**(If Class A Conditions are Involved, Substitute the Following)**

Our investigation indicates that neither the manufacturer nor the
assembler is likely to be responsible for the noncompliances under the
regulations. These problems may pose a serious health hazard to the
patient or operator. We strongly encourage you to discontinue use of the
system and arrange for its repair immediately.

You are hereby requested to notify this office in writing, within 30
working days of receipt of this letter, of the specific steps you have
taken to correct the noted noncompliance. If corrective action cannot be
completed within 30 working days, state the reason for the delay and the
time within which the corrections will be completed. Your response
should be sent to [(name)]{.underline} , Compliance Officer, Food and
Drug Administration, [(street address)]{.underline} ,
[(city)]{.underline} , [(state & zip code)]{.underline}. If you have any
questions, [(name)]{.underline} can be contacted at [(telephone
#)]{.underline} .

Sincerely yours,

Note: Indicate at the bottom of the original letter that the state
radiation control program has received a copy of this letter.

[RESPONSIBILITY FOR DEFECTS AND NONCOMPLIANCES]{.underline}

The Diagnostic X-ray Performance Standard specifies certain limits of
responsibility for manufacturers and assemblers of x-ray equipment.
Assemblers are responsible only for noncompliances that are \"attributed
solely to improper assembly or installation\...\" caused by improperly
following the instructions provided by the manufacturer. Manufacturers
are responsible for noncompliances caused by improper assembly only if
adequate instructions were not provided to the assembler (1020.30(c)).
The performance standard does not specifically address the limits of
responsibility regarding equipment age or user responsibility.

Manufacturers are required by the performance standard to provide
purchasers with a schedule of maintenance necessary to keep the x-ray
equipment in compliance with the performance standard. The regulations
require manufacturers to provide a maintenance schedule because it is
unreasonable to expect x-ray equipment to meet certain performance
requirements if proper maintenance is not performed. After the first
maintenance is performed or after the time it should have been
performed, the assembler may no longer be responsible for requirements
affected by proper adherence to the maintenance schedule. Some
assemblers of older certified equipment will correct the noncompliance
and bill the owner rather than attempting to refute responsibility for
the noncompliance. This practice frequently upsets the x-ray system
owner since he believes this work should have been performed free of
charge.

Evidence that would exempt manufacturers/assemblers from responsibility
includes:

l\. Failure by the user to follow the manufacturer\'s prescribed
maintenance schedule for those items requiring periodic adjustment.

2\. Photographs or other documentation (written description) of physical
damage to the x-ray system which was due to abuse.

The manufacturer/assembler may be held responsible if the user has
failed to follow the maintenance schedule but the facility has
documented continued compliance problems with the system beginning in
the warranty period.

Items that may require periodic adjustment under a manufacturer\'s
maintenance schedule include:

a\) linearity

b\) x-ray field/light field alignment

c\) PBL sizing

d\) illuminance

e\) entrance exposure rate

f\) fluoroscopic alignment

g\) spot film alignment

h\) indication of technique factors

i\) signal and warning lights

Some items require adjustment on a time basis while others require
adjustment at time of a tube reloading or bulb change in the collimator
lamp. The individual maintenance schedule must be checked to determine
the applicable situation and time interval.

LIST OF QUALIFIED X-RAY AUDITORS

PHONE NUMBER/FAX NUMBER

New England District Michael J. Leal 508-793-0422

508-793-0456

New York District Vacant 516-921-2035

516-921-3025

Baltimore District Elizabeth Laudig 410-962-3591x159

410-962-2219

Cincinnati District Terry R. Bolen\* 513-679-2700x138

513-679-2772

New Jersey District Tonietta K. Williams 973-526-6018

Philadelphia District Rita Larocca 251-362-0740

Robert E. Davis 412-644-3394x13

412-644-5496

Atlanta District Thomas D. Clarida\*

Florida District Janneth Caycedo\* 561-338-5236x23

407-367-8685

New Orleans District Karen Smallwood 615-781-5380x144

Abraham Maekele 901-544-0345x20

615-781-5391

New Orleans District Francis Guidry\* 337-262-6603

337-262-6678

San Juan District Jorge Martinez\*

Chicago District Dennis E. Swartz\* 313-226-6260x155

Detroit District Dennis E. Swartz 313-226-6260x155

Leonard Pesetsky 313-226-6260

313-226-3717

Minneapolis District Thomas W. Garvin 414-771-7167x12 414-771-7512

Dallas District John D. Mays 214-655-8100x125 Deborah McGee
214-655-8100x138

Scotty L. Hargrave 214-655-8100x139

Angela T. Moak 214-655-8100x135

214-655-8130

Kansas City District Reggie Cope 913-752-2403

St. Louis District Reggie Cope\* 913-752-2403

913-752-2413

Denver District Robert G. Antonsen 303-236-3025

303-236-3551

Los Angeles District Ron Alexander 949-798-7703

San Francisco District Minh Phan 949-798-7711

949-798-7794

Seattle District John Hall 425-483-4932

425-483-4915

\*Providing auditor functions for district

[WARNING LETTER]{.underline}

(SAMPLE DISTRICT ORDERED ASSEMBLER RECALL LETTER TO

X-RAY ASSEMBLERS)

[CERTIFIED MAIL]{.underline}

[RETURN RECEIPT REQUESTED]{.underline}

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM\'S COMPLETE ADDRESS

Dear [(Addressee)]{.underline} :

Field compliance testing of fully certified diagnostic x-ray systems
assembled by [(firm name)]{.underline} since [(date)]{.underline} has
shown that [(number,]{.underline} [i.e.: 43)]{.underline} percent of the
x-ray systems tested failed to comply with the Performance Standard for
Diagnostic X-ray Systems and Their Major Components (Performance
Standard). Diagnostic x-ray equipment are devices as defined by Section
201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). The Food
and Drug Administration (FDA) has issued [(number, i.e.:
12)]{.underline} letters to you addressing your firm\'s noncompliant
assemblies, yet you continue to install diagnostic x-ray systems which
fail to comply with the Performance Standard. Based on this high rate of
noncompliance with the Performance Standard and your inability to
provide assurance that x-ray systems which you assemble will comply with
the Performance Standard, the FDA has determined that you fail to comply
with Title 21, [Code of Federal Regulations]{.underline} (21 CFR),
section 1020.30(d). The FDA, hereby declares your assemblies since
[(date)]{.underline} as noncompliant. As noted below you are hereby
required to provide user notification and corrective action plan (CAP)
for the recall of your assemblies.

You are advised that it is a prohibited act under the Federal Food,
Drug, and Cosmetic Act, section 538 of Subchapter C ‑ Electronic Product
Radiation Control (formerly the Radiation Control for Health and Safety
Act of l968), to fail to correct electronic products that do not comply
with an applicable standard, or that have a defect which relates to the
safe use of such products. Additionally, under the Act, it is a
prohibited act to adulterate a medical device after receipt in
interstate commerce. Your installations are in violation of 21 U.S.C.
351(c) because they fail to have the quality that they purport or are
represented to possess in that they do not comply with the Performance
Standard for Diagnostic X-ray Systems and Their Major Components, 21 CFR
1020.30.

You must respond in writing within 15 working days of receipt of this
letter and provide the number of x-ray assemblies you have completed
since [(date)]{.underline} . In responding, you have the following
options:

A. Refutation ‑ You may submit your views and evidence to establish that
the alleged noncompliances do not exist.

[NOTE:]{.underline} Should your refutation not be accepted, you may
request a Regulatory Hearing to state your views in accordance with 21
CFR 1003.11(a)(3).

B. Exemption Request ‑ You may request an exemption from user
notification and from the obligation to correct the violative
assemblies. Your request must include the grounds upon which you base
the exemption request (see 21 CFR 1003.30 and 1003.31).

C. Purchaser Notification and Corrective Action ‑ If you neither refute
the noncompliances nor request an exemption, you must; (1) notify
purchasers of the violative products as specified in 21 CFR 1003.10(b),
and (2) submit a written corrective action plan (CAP) to fulfill your
obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of
the violative products.

1\. Notification Letters ‑ Requirements for preparing notification
letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the
notification letter to be sent to purchasers should also be sent to this
office for review before it is sent to purchasers.

2\. Corrective Action Plan ‑ Requirements for preparing a CAP may be
found in 21 CFR 1004.2, 1004.3, or 1004.4. Note: the cost of any service
or correction of violations by FDA directive is not to be passed on to
the owner or user.

If you require additional time to prepare your refutation, notification,
CAP, or evidence to support an exemption request, you must submit within
15 working days of the receipt of this letter a written request to this
office which outlines the reasons for any delays and a reasonable target
date for submission of your response. If your response is not received
within 15 working days, the FDA may consider you to be in violation of
section 538(a)(2) of the Act for failure to submit required reports.

Please be advised that if your refutation or exemption request is not
accepted by the FDA, you must submit a CAP for all certified diagnostic
x-ray systems you have assembled since [(date)]{.underline} . An
acceptable CAP submission must include:

1\. An agreement to test all assemblies of certified components
installed since (date), to ensure that all assemblies comply fully with
the Performance Standard.

2\. A statement of the testing to be performed, and a copy of the test
method.

3\. An agreement to correct any items of noncompliance detected by the
above testing, at no cost to the user. If you can document that the
noncompliance is directly attributed to user abuse or attributable to
servicing by another party, you may submit this evidence in lieu of
correcting the noncompliance.

4\. A listing of all equipment to be used in the testing and calibration
of diagnostic x-ray systems.

5\. An agreement that all equipment that will be used in testing and
calibration will be within current calibration.

6\. The number of certified systems assembled since (date).

7\. A timetable for the correction of all affected systems.

8\. An agreement to submit copies of all test data for FDA review.

9\. A copy of the notification letter to be sent to affected purchasers
or a draft of said letter.

10\. Provisions to ensure that all future assemblies of certified
diagnostic x-ray systems comply with all aspects of the Performance
Standard.

Failure to promptly correct this violation(s) can result in regulatory
action being initiated by the Food and Drug Administration without
further notice. These actions include seizure and/or injunction and/or
the imposition of civil penalties as provided for in section 539 of the
Act. Persons violating section 538 of the Act are subject to civil
penalties of up to \$1,000 per violation and up to a maximum of
\$300,000.

You should notify this office in writing, within 15 working days of
receipt of this letter, of the specific steps you have taken to correct
the noted violation(s), including an explanation of each step taken to
prevent the recurrence of similar violations. If corrective action
cannot be completed within 15 working days, state the reason for the
delay and the time within which the corrections will be completed.

Your response should be sent to [(Name)]{.underline} , Compliance
Officer, Food and Drug Administration, [(street address)]{.underline} ,
[(City, State & zip code)]{.underline} . If you have any questions,
[(name)]{.underline} can be contacted at [(telephone #)]{.underline}.

Sincerely yours,

District Director

Enclosures

(GUIDANCE FOR EVALUATING AN ASSEMBLER RESPONSE TO A DISTRICT

ORDERED ASSEMBLER RECALL)

The Federal Food, Drug, and Cosmetic Act (the Act), section 538 of
Subchapter C ‑ Electronic Product Radiation Control (formerly the
Radiation Control for Health and Safety Act of l968) affords
manufacturers the opportunity to respond to a declaration of defect or
noncompliance in one of three ways:

1\. Submit evidence to refute the alleged defect or noncompliance.

2\. Submit an exemption request.

3\. Submit a corrective action plan (CAP).

Generally, noncompliance declarations are prepared in the expectation
that the manufacturer will willingly submit a CAP. In reality, some
manufacturers appear to have in place a strategy of first attempting to
refute the cited noncompliance, then seeking an exemption, and if not
successful, submitting a CAP. While such strategy may seem like
stonewalling or foot dragging by the manufacturer, this is perfectly
legal under the Act.

[Evaluating Refutations]{.underline}

If an assembler can demonstrate that more than one individual
noncompliant system was not attributable to improper assembly or
calibration, he may have a valid refutation for the declaration of
noncompliance. The statistics involved in identifying assemblers for
coverage in this program are such that a shift of one or two violations
greatly affects the decision to pursue a District Ordered Assembler
Recall (DOAR). Because of this, we do not include any field tests which
are reported to be of manufacturer origin, or are reported as being in
dispute.

The refutation must, of course, have a sound basis. The assembler should
submit copies of test data and the test method to demonstrate the system
fully complied with the Performance Standard at the time of assembly.
Unless such evidence is presented, there is no valid basis for the
assembler certification of the respective system.

If you would like assistance in evaluating a refutation, please contact
the Diagnostic Devices Branch (HFZ‑322) at (301) 594‑4591.

[Exemption Requests]{.underline}

Exemption requests are permitted by FDA regulations, 21 CFR 1003.30. The
regulations require the manufacturer to submit his exemption request in
writing, within 15 working days of receiving a declaration of defect or
noncompliance. In the case where refutation has been denied, the
exemption request must be submitted within 15 working days of receiving
written denial of the refutation.

Exemption requests may be granted only if the manufacturer submits
evidence to demonstrate the failure to comply with the Performance
Standard does not create a significant risk of injury, including genetic
injury, to any person. Since the capability to evaluate such submission
does not exist in most FDA District offices, all exemption requests
should be forwarded to the Diagnostic Devices Branch (HFZ‑322) for
evaluation. The Diagnostic Devices Branch will provide the district with
their evaluation and a determination as to the acceptability of the
exemption request.

Please note that a manufacturer who has his exemption request denied may
contest the denial in a hearing by the Secretary. It is essential
therefore, that all exemption requests be submitted to HFZ‑322 for
proper evaluation.

If an exemption is granted, no further action is required. Since
granting an exemption implies no significant hazard to the user, the
violative systems cited may not be used for future legal action (civil
penalty or injunction) for the same specific violation.

Please note that the Center does not expect to approve many exemption
requests, due to the implied health hazard presented by violative field
test results.

When the Center\'s evaluation of the exemption request is received in
the district, it will contain either a draft denial letter, or draft
approval letter. If the exemption request is denied, the manufacturer is
required to submit a CAP within 15 working days of receiving the denial
letter. The return receipt should be maintained as evidence of receipt
by the manufacturer.

[Corrective Action Plan]{.underline}

Corrective action plans (CAPs) must include one of the following
options:

1\. Repair the noncompliant products.

2\. Refund the purchase price of noncompliant product.

3\. Replace the noncompliant products with compliant products.

Of the three options, most manufacturers elect to repair the
noncompliant components. Since the other two options do not require
explanation, only the repair option will be discussed further.

The underlying philosophy of declaring as noncompliant all diagnostic
x-ray systems installed over certain time period presupposes that
combined FDA/State testing has not tested all systems installed by a
particular assembler. This implies that there exist other assemblies
(not tested by FDA or the State) of diagnostic x-ray equipment which
also fail to comply. The purpose of the noncompliance declaration is to
obtain a CAP which will require the testing (and correction) of
previously untested system.

An acceptable CAP will contain the following elements:

1\. The assembler\'s proposed method of re-testing all assemblies of
certified components installed within specified time period. (CDRH will
help the district with the time frame to be cited in the noncompliance
declaration.)

2\. A statement of the testing to be performed and a copy of the test
method.

3\. A listing of all equipment to be used in the testing.

4\. Documentation that all equipment used in the testing will be
properly calibrated.

5\. The number of certified systems assembled during the period covered
by the noncompliance declaration.

6\. A timetable for the correction of all affected systems.

7\. Provisions to submit copies of all test data for FDA view.

8\. A draft notification letter to affected purchasers or a copy of the
letter that was sent.

Assemblers certainly will not submit such detailed information in their
initial response to the district. Once a CAP is received, the district
should perform a review, and if further guidance is required, contact
the Diagnostic Devices Branch (HFZ‑322) at (301) 594‑4591. Since
submission of a CAP represents a commitment to correct the violative
products, an establishment inspection should be scheduled to collect the
recall information required by the R & R.

During this inspection the investigator may obtain the above commitments
regarding the CAP. If an inspection cannot be conducted in a timely
manner, a letter to the assembler requesting the required information
may be sent in lieu of an establishment inspection.

An establishment inspection at this point may check that all items
enumerated above can be provided. The investigator should confirm the
following:

‑ The assembler has the test equipment to perform the required testing.

‑ Measurement equipment is properly calibrated.

‑ The adequacy of any test method to be used in compliance testing.

‑ The assembler has maintained records for tracing assemblies of
diagnostic x-ray systems.

‑ The assembler has adequate personnel to perform the testing.

‑ The assembler is capable of meeting specified timetables for
correction of all systems.

You should consider granting a 30‑day grace period for submitting the
above information. Assemblers may require this much time to prepare an
adequate CAP. If additional time is required, advise the assembler in
writing that he must provide the user notification to affected
purchasers within 15 working days of receiving this letter or he will be
in violation of The Federal Food, Drug, and Cosmetic Act (the Act),
section 538(a)(2) of Subchapter C ‑ Electronic Product Radiation Control
(formerly the Radiation Control for Health and Safety Act of l968).

[Please note:]{.underline} Exemptions usually only apply to products
already introduced into commerce, not to future or ongoing
installations. A variance may be requested and granted for a
manufacturer to continue the introduction of products into commerce
which do not comply with a part of the Performance Standard in
accordance with 21 CFR 1010.4.

**(SAMPLE USER NOTIFICATION LETTER FOR DISTRICT ORDERED**

**ASSEMBLER RECALL AND CAPS)**

[CERTIFIED MAIL RETURN RECEIPT REQUESTED]{.underline}

DOCTOR\'S NAME

FIRM NAME

FIRM\'S COMPLETE ADDRESS

Dear [(Addressee)]{.underline} :

[(Firm name i.e.: ABC X-ray Company)]{.underline} has been advised by
the Food and Drug Administration (FDA) that diagnostic x-ray systems
assembled by [ABC X-ray Company]{.underline} since January 1, 1985, may
fail to comply with the Performance Standard for Diagnostic X-ray
Systems and Their Major Components (Performance Standard). The FDA
advised that [(number,]{.underline} [i.e.: 43)]{.underline} percent of
the [(number, i.e.: 27)]{.underline} systems they tested failed to
comply with the Performance Standard for Diagnostic X-ray Systems and
Their Major Components, Title 21, [Code of Federal]{.underline}
[Regulations]{.underline}, Section 1020.30.

We are working with the FDA to develop a plan for testing all diagnostic
x-ray systems we have installed since [(date, i.e.: June 1,]{.underline}
[1985).]{.underline} Any system we test which fails to comply with the
Performance Standard will be adjusted and re-calibrated as necessary to
correct the noncompliance. This will be done at no cost to you, the
purchaser/ user.

Correction of noncompliant diagnostic x-ray systems is a requirement of
the Federal Food, Drug, and Cosmetic Act, section 538 of Subchapter C ‑
Electronic Product Radiation Control (formerly the Radiation Control for
Health and Safety Act of l968).

We shall contact you shortly to test your diagnostic x-ray system, and
make the necessary adjustments.

Sincerely,

John Doe

[ABC X-ray Company]{.underline}

**(SAMPLE CAP APPROVAL LETTER TO X-RAY ASSEMBLERS)**

[CERTIFIED MAIL]{.underline} - [RETURN RECEIPT REQUESTED]{.underline}

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM\'S COMPLETE ADDRESS

Dear [(Addressee)]{.underline} :

On [(date)]{.underline} , the FDA sent you a letter advising that
between [(mo./day/yr.)]{.underline} and [(mo./day/yr.)]{.underline} ,
[(number, i.e. 43)]{.underline} percent of your assemblies of certified
diagnostic x-ray systems which were tested for compliance with the
Performance Standard for Diagnostic X-ray Systems and Their Major
Components (Performance Standard) failed to comply. Of the three options
outlined in our letter, you elected to submit a corrective action plan
(CAP). A partial CAP was submitted in our letter of [(mo./day/yr.)
.]{.underline}

On [(date)]{.underline} , FDA Investigator[(s)]{.underline} from this
office visited your firm to obtain further information concerning the
details of your proposed CAP. On [(date)]{.underline} , you submitted
additional information which resulted in your CAP submission being
complete.

We understand that you intend to conduct your CAP as follows:

1\. You will identify all installations of fully certified diagnostic
x-ray systems which you assembled between [(mo./day/yr.)]{.underline}
and [(mo./day/yr.) .]{.underline}

2\. You will notify all affected purchasers (via certified mail)
concerning your CAP.

3\. You will retest all assemblies of fully certified diagnostic x-ray
systems (which have not previously been tested by FDA) reported in 1. to
determine if each system is in full compliance with the Performance
Standard.

4\. You will correct all items of noncompliance which you encounter
during your retests. You will also notify this FDA office of each of the
noncompliances you encounter.

5\. .

6\. .

We are approving your CAP contingent upon the following:

1\. You will submit monthly status reports which include: (1) the number
of systems to be corrected, (2) the number of purchaser notification
letters sent, (3) the number of letters returned as undeliverable, (4)
the number of systems tested, (5) the number of systems which were
noncompliant, and (6) the number of noncompliant systems which were
corrected, including details of each noncompliance

[Purchaser notification will be made in accordance with all requirements
of 21 CFR 1003.21.]{.underline} This office is to be included in the
notification process as if it were a purchaser.

2\. .

You may commence implementation of your CAP upon receipt of this letter.

Please note that the [ABC X-ray Company]{.underline} is responsible for
the correction of all certified x-ray systems which you have assembled
between [(mo./day/yr.)]{.underline} and [(mo./day/yr.)]{.underline} .
Should your CAP prove ineffective, we reserve the right to require you
to take more stringent measures.

The Food and Drug Administration classifies corrective action plans for
diagnostic x-ray products as recalls. We shall shortly notify you of the
classification of this recall and the FDA recall number. When making
monthly reports or in any future correspondence relating to this CAP,
please reference the recall number. Monthly status reports should be
sent to:

> [(Name)]{.underline}
>
> Recall and Emergency Coordinator, HFR‑
>
> Food and Drug Administration
>
> [(Street address)]{.underline}
>
> [(City, State and zip code]{.underline})

Please be advised that it is FDA policy to report facts surrounding all
noncompliances with the Performance Standard in the FDA Enforcement
Report. This publication is available to the public.

If you have any questions concerning this matter, please contact
[(name)]{.underline} at [(address)]{.underline} , [(telephone
number)]{.underline} .

Sincerely yours,

District Director