May 30, 2002

Item: Philips/Agilent/Hewlett Packard Viridia information centers;
central station monitors using the Hewlett Packard Vectra VL400 personal
computer. This PC is used in models M3150A, M3151A, M3153A and
M3150AU#A01 central station monitors. All units shipped between Feb 1,
2001 and Feb 21, 2000 are affected. Bedside monitors are NOT affected.

Specific Incident: The hard disk drive installed in the units may fail,
causing loss of central station monitoring and alarming. Bedside
monitoring and alarms are not affected.

Action: 1. If you have the affected units and did not already receive
and respond to Philips Medical Systems letter (attached), immediately
(within 24 hours) check your central station monitoring serial numbers
against the list in the attached letter from Philips Medical.

> 2\. If affected, contact Philips Medical at (800) 548-8833 to arrange
> replacement of the hard drives.

Additional Information:

> Some other Philips systems have this same problem, but these failures
> do not affect patient safety. These units are also identified in the
> attached letter. Please review the letter and contact Philips as
> needed. Also, please contact Paul Sherman at CEOSH via e-mail if you
> are affected by this recall and did not receive Philips' letter.

Source: CEOSH and Manufacturer

Contact: Philips Technical Support at (800) 548-8833. You can also
contact Paul Sherman, VA Center for Engineering & Occupational Safety
and Health (CEOSH) at (314) 543-6700.

###### Philips Medical Systems

300 Minuteman Road

Andover, MA 01810

April 2002

Dear Biomedical Engineering Manager,

Through our product quality surveillance system, Philips Medical Systems
has become aware of an issue with medical devices used for central
monitoring, obstetrical care, enhanced ECG analysis and documentation
management. These devices may have been distributed with Hewlett-Packard
Vectra VL400 PCs containing disk drives with a higher than expected
failure rate.

**Voluntary Medical Device Recall**

Philips Medical Systems has initiated a voluntary recall for the
following products which may be affected by premature hard disk drive
failure: Agilent and Viridia Information Centers, model numbers M3150A,
M3151A, M3153A and M3150AU#A01.

**Voluntary Medical Device Correction**

Philips Medical Systems has initiated a medical device correction for
the following products which may be affected by premature hard disk
drive failure but do not pose a risk to patient safety: Agilent
Technologies OBTraceVue, model numbers: M1382B, M1383B, M1384B, M1385B,
M1383C and M1384C; Agilent Technologies MIDA System, model# M2040A;
Agilent Technologies Inter-SDN Gateway, model# M1272A

You are being contacted because our shipping records indicate that your
facility has received an Agilent or Viridia Information Center. Attached
to this letter you will find the Medical Device Recall that provides
instructions on how to identify the affected units and what actions are
required of your facility.

If you feel you may have other products affected by the medical device
correction program for which instructions are not attached to this
letter, please contact the Philips Medical Support line at
1-800-548-8833.

We sincerely regret the inconvenience that this will cause you. Your
satisfaction with Philips Medical products and with our response to this
problem is very important to us.

Sincerely,

Elisabeth George

Vice President of Quality and Regulatory

Philips Medical Systems

Cardiology and Monitoring Systems

**Philips Medical Systems URGENT: MEDICAL DEVICE RECALL**

300 Minuteman Road Agilent and Viridia Information Center

Andover, Ma 01810 M3150A, M3151A, M3153A, M3150AU#AOI

**April** 2002

+------------+---------------------------------------------------------+
| **         | **Products:** Information Center System and Upgrades    |
| AFFECTED** |                                                         |
|            | M3150A Agilent or Viridia Information Center            |
| **         |                                                         |
| PRODUCTS** | M3151A Agilent or Viridia Information Center Client     |
|            |                                                         |
|            | M3153A Agilent or Viridia Surveillance Center           |
|            |                                                         |
|            | M3150AU#AO1 Agilent or Viridia Information Center       |
|            | Upgrade                                                 |
|            |                                                         |
|            | **Units Affected:** Systems distributed with            |
|            | Hewlett-Packard Vectra VL400 personal computers         |
|            | (\"PC\") with serial numbers listed on page 3 of this   |
|            | notice. Systems were shipped between February 1, 2001   |
|            | through February 21, 2002                               |
|            |                                                         |
|            | **Manufactured and Distributed by:** Agilent            |
|            | Technologies Healthcare Solutions Group and Philips     |
|            | Medical Systems\*.                                      |
|            |                                                         |
|            | \* Agilent Technologies Healthcare Solutions Group was  |
|            | acquired by Royal Philips Electronics on August 1.      |
|            | 2001.                                                   |
+------------+---------------------------------------------------------+
| **REASON** | Hewlett-Packard Vectra VL400 PCs (HP Part# P3715W) with |
|            | the listed serial numbers may contain disk drives with  |
| **FOR      | a higher than expected failure rate.                    |
| RECALL**   |                                                         |
+------------+---------------------------------------------------------+
| **HAZARD   | Loss of central patient monitoring and central patient  |
| INVOLVED** | alarming                                                |
|            |                                                         |
|            | There is no prior indication or warning of the disk     |
|            | drive failure.                                          |
|            |                                                         |
|            | Bedside monitoring and alarming is unaffected.          |
+------------+---------------------------------------------------------+
| **HOW TO** | See the attached photographs for system identification  |
|            |                                                         |
| **         |                                                         |
| IDENTIFY** |                                                         |
+------------+---------------------------------------------------------+
| **REQUIRED | Using the directions on the following pages, identify   |
| ACTION**   | the PCs that will require the hard disk drive           |
|            | replacement.                                            |
|            |                                                         |
|            | You will receive a call from a Philips Medical Systems  |
|            | representative to schedule a repair.                    |
|            |                                                         |
|            | If you have questions about this recall notice, please  |
|            | call the Philips Medical Support line at                |
|            | 1-800-548-8833.                                         |
+------------+---------------------------------------------------------+

M3150A, M3151A, M3153A, M3150AU#AOI

System Identification

+------------------------+---------------------------------------------+
| **How to identify if   | Information Center Display                  |
| you have an Agilent or |                                             |
| Viridia Information    | ![](med                                     |
| Center subject to the  | ia/image1.png){width="2.1979166666666665in" |
| recall**:              | height="1.8333333333333333in"}              |
|                        |                                             |
| Locate the display and | The Information Center                      |
| the PC for the         |                                             |
| Information Center     | display will look similar                   |
|                        |                                             |
| The hard drive to be   | to this                                     |
| replaced resides       |                                             |
| within the             | **[Information Center PC]{.underline}**     |
| Hewlett-Packard Vectra |                                             |
| VL400 PC.              | ![](media/image2.png){width="2.625in"       |
|                        | height="2.03125in"}                         |
| If your Information    |                                             |
| Center PC is not a     | The PC may or may                           |
| Hewlett- Packard       |                                             |
| Vectra VL400, it is    | not be located with                         |
| not affected by this   |                                             |
| recall.                | the display                                 |
|                        |                                             |
| **Once you have        | ![](med                                     |
| identified the [PC     | ia/image3.png){width="1.9583333333333333in" |
| serial                 | height="2.4583333333333335in"}              |
| number,]{.underline}   |                                             |
| refer to the next page | The PC will have a                          |
| to determine if your   |                                             |
| unit needs a           | label located on the                        |
| replacement drive**    |                                             |
|                        | top that identifies                         |
|                        |                                             |
|                        | the unit and the PC                         |
|                        |                                             |
|                        | serial number                               |
|                        |                                             |
|                        | The PC serial                               |
|                        |                                             |
|                        | Number can also be                          |
|                        |                                             |
|                        | found on the back of                        |
|                        |                                             |
|                        | the unit                                    |
+------------------------+---------------------------------------------+

+--------------------------------+-------------------------------------+
| If your device\'s PC serial    | Serial Numbers of Affected PC\'s    |
| number is listed here, then it |                                     |
| requires a replacement drive.  | **(Hewlett-Packard Vectra VL400, HP |
|                                | Part# P371SW)**                     |
| A Philips Representative will  |                                     |
| be calling you shortly to      | US1 0204040 through US1 071 0329    |
| schedule an appointment to     |                                     |
| perform the replacement        | US1 0811665 through US10811789      |
|                                |                                     |
|                                | US10902444                          |
|                                |                                     |
|                                | US10902817 throughUS10902887        |
|                                |                                     |
|                                | US11304210                          |
|                                |                                     |
|                                | US11304576 through US11304670       |
|                                |                                     |
|                                | US11307358                          |
|                                |                                     |
|                                | US11307974 through US11500994       |
|                                |                                     |
|                                | US11608246                          |
|                                |                                     |
|                                | US11608393 throughUS11703817        |
|                                |                                     |
|                                | US11704443                          |
|                                |                                     |
|                                | US11709038 through US11709052       |
|                                |                                     |
|                                | US11800005                          |
|                                |                                     |
|                                | US11800291 through US11904733       |
|                                |                                     |
|                                | US121 04028                         |
|                                |                                     |
|                                | US121 04584 through US121 04621     |
|                                |                                     |
|                                | US121 06958                         |
|                                |                                     |
|                                | US121 07167 through US121 07365     |
|                                |                                     |
|                                | US12203988                          |
|                                |                                     |
|                                | US 12203996 through US 12204354     |
|                                |                                     |
|                                | US1221 0341                         |
|                                |                                     |
|                                | US1221 0494 through US1221 0535     |
|                                |                                     |
|                                | US1221 0537                         |
|                                |                                     |
|                                | US1221 0539 through US1221 0575     |
|                                |                                     |
|                                | US1221 0579                         |
|                                |                                     |
|                                | US1221 0581                         |
|                                |                                     |
|                                | US1221 0583 through US1221 0622     |
|                                |                                     |
|                                | US12403504                          |
|                                |                                     |
|                                | US12403528 through US12408065       |
|                                |                                     |
|                                | US12408067                          |
|                                |                                     |
|                                | US12408070 throughUS12408085        |
|                                |                                     |
|                                | US12608928                          |
|                                |                                     |
|                                | US12609515 through US12609752       |
|                                |                                     |
|                                | US12609757 through US12609883       |
|                                |                                     |
|                                | US12618799                          |
|                                |                                     |
|                                | US12618806 through US12618807       |
+--------------------------------+-------------------------------------+

M3150A, M3151 A, M3153A and M3150AU#AO1 Recall Notice

# System Identification