DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration 

Center for Devices and Radiological Health

ACCIDENTAL RADIATION OCCURRENCE REPORT

Form Approved: 

OMB Number 0910-0025 

Expiration Date: February 28, 2026

See Burden Statement on page 5.

Note: Items with an asterisk (*) require a response.

SUBMITTER INFORMATION

If you are not submitting this report representing the manufacturing establishment for the radiation-emitting product causing 

the problem, you may enter your own company name under Establishment Identification and Submitter Address, or enter N/A 

and provide your home or other address.

Contact Information

Contact Name (Title, first name, last name)* Occupation Title

Email Address*

Establishment Identification (Manufacturer of the radiation-emitting product being reported, if known)

Establishment Name

Division Name

Submitter Address

Address

Street*

City* State* Zip Code*

Telephone Number*

Fax Number

INFORMATION REGARDING PRODUCT MANUFACTURER

Product Manufacturer Name (If known)

Product Manufacturer Address (If known)

Street (Line 1) Street (Line 2)

City Territory, Province, or State Country Zip or Postal Code

Product Model Designation (If known)

Model Name or Number Model Family Designation Brand Name

Please provide any other information known regarding the manufacturer of the product that was involved in the accidental 

radiation exposure incident.

If you are aware that the manufacturer was informed about the incident, please provide the contact information below.

Contact Information (Including whom you contacted and address) Date Contacted

FORM FDA 3649 (05/23) PAGE 1 of 5 PSC Publishing Services (301) 443-6740 EF
PRODUCT INFORMATION

Product Types (Please select the best match (only one). Note that product types are grouped into radiation categories.)

Acoustic Radiation

Therapeutic Ultrasonic Devices (Including diathermy and 

stimulators)

Ultrasonic Medical Devices (Miscellaneous) (Including 

lithotriptors)

Diagnostic Ultrasound Devices

Sonic Medical Products (Including hearing aids and 

vibrators)

Ultrasound Non-Medical Products (Including jewelry 

cleaners and intrusion security systems)

Sonic Non-Medical Products

Veterinary Diagnostic Ultrasonic Products

Veterinary Therapy Ultrasonic Products

Other Sonic or Ultrasonic Product

Ionizing Radiation

Personnel Security Systems (Including backscatter and 

transmission x-ray systems)

Cargo Non-Intrusive Security Systems 

Cabinet X-Ray Systems, Non-Medical (Including baggage 

x-ray systems)

Industrial X-Ray Systems (Excluding Cabinet) 

Analytical X-Ray Systems, Non-Medical 

High Voltage Vacuum Switches 

Industrial Particle Beam Systems 

TVs and video monitors (Not including flat-screen TVs)

Medical Diagnostic X-Ray Equipment 

Dental Diagnostic X-Ray Equipment 

Therapeutic X-Ray Systems 

Veterinary X-Ray Systems 

X-Ray Bone Densitometers 

X-Ray Film and Film Processing Materials

Cabinet X-Ray Systems, Medical 

Medical Accelerators 

Non-Medical Accelerators 

High Voltage Vacuum Tubes 

Cathode Ray Tube (Without Electronics Chassis) 

Cold-Cathode Gas Discharge Tubes 

Other X-Ray Product

Microwave EMF Radiation

Microwave Ovens (Food Prep) 

Microwave Hyperthermia Therapy Devices 

Microwave Diathermy Machines 

Microwave Identification, Safety, Security, and Surveillance 

Products 

Industrial Dielectric Heaters 

Microwave Medical Products 

Microwave Heating and Drying Products 

Microwave Communication, Data Transmit, and 

Measurement Products (Including CB radios, cell phones, 

walkie-talkies, household remote controllers)

Nuclear Magnetic Resonance Devices 

Household ELF Products (Including electric blankets)

Other Microwave Product

Microwave EMF Radiation (Continued)

Optical Radiation

Medical Laser Products (Including surgical devices and 

laser therapy)

Surveying, Leveling, Alignment Laser Products (Including 

laser pointers, laser levels)

Laser Light Show/Display Products 

Toy, Novelty, Play Laser Products 

Safety, Security, Surveillance Laser Products (Including 

night vision systems, traffic speed systems and intrusion 

detection systems)

Research, Scientific, Laboratory Laser Products 

Material Processing Laser Products (Including welders, 

cutters, engravers)

Data Measurement, Transmit, Control Laser Products 

(Including fiber optic communication systems, laser vision 

systems and process control systems)

Utility/Peripheral Laser Products (Including laser printers, 

bar code scanners, CD and DVD systems)

In Vitro and Other Medical Laser Products (Including 

Veterinary devices)

Patient Positioning Medical Laser Products 

Other Laser Products 

Sunlamp Products (Including sunlamps and tanning beds)

Mercury Vapor Lamps 

Ultraviolet Medical Products 

Ultraviolet Commercial/Consumer Products 

Ultraviolet Surveillance & Detection Products 

Ultraviolet Hygiene Products (Including UV sanitizers)

General Optical Products, Medical (Including surgical 

lamps)

General Optical Products, Non-Medical (Including LEDs 

and fluorescent lamps)

FORM FDA 3649 (05/23) PAGE 2 of 5
PRODUCT INFORMATION (Continued)

Product Description

Description of product and its intended use

ACCIDENTAL RADIATION OCCURRENCE INFORMATION

Location of Occurrence

Please provide the physical location where the Accidental Radiation Occurrence took place (e.g., at a residence, a factory, a 

tanning salon, school, restaurant, airport, etc.). If you do not know the exact address, provide responses to the best of your 

ability, or enter "Unknown."

Location or Establishment Name

Specific Section of Location or Establishment (If applicable)

Address

Street

City State Zip Code

Telephone Number

Fax Number

Date of Event* From To Web Address

Persons Involved

Number of people exposed in the 

Accidental Radiation Occurrence*

Number of people 

adversely affected*

Number of unexposed 

people who were involved*

Number of potentially exposed people 

who have not exhibited any adverse 

reactions*

Type of reportable event Death Serious Injury Malfunction Other .

Description of the nature and magnitude of exposure and/or injuries

FORM FDA 3649 (05/23) PAGE 3 of 5
ACCIDENTAL RADIATION OCCURRENCE INFORMATION (Continued)

Description of the Radiation Occurrence

Is this a new Accidental Radiation Occurrence (ARO) report or a supplement to a previous ARO report filed by you or your organization? 

(Please select one.)*

New ARO report Supplement to previous ARO report (Enter date of previous report below.)

Date of previous ARO report, if applicable (mm/dd/yyyy) (Required entry* only if “Supplement to previous ARO report” is selected.)

Description of circumstances surrounding the accidental radiation occurrence (Please include a description of the activities leading 

up to the event and actions that occurred during the event, as well as any suspected causes of the occurrence.)*

Actions Taken

The actions described below are those taken to control, correct, or eliminate the causes and to prevent reoccurrence. If 

unknown, you may state "Unknown" below.

Description of specific actions, to date, taken by the manufacturer in response to the Accidental Radiation Occurrence*

FORM FDA 3649 (05/23) PAGE 4 of 5
ACCIDENTAL RADIATION OCCURRENCE INFORMATION (Continued)

Actions Taken (Continued)

Description of future actions to be taken by the manufacturer, if known, in response to the Accidental Radiation Occurrence (If this is a 

preliminary ARO report from the manufacturer, please indicate that further investigation is ongoing.)*

If this involved a medical device, has a Medical Device Report (MDR) been submitted to FDA?*

Yes No N/A Unknown

Other Important Information (Please enter below)

Feel free to send in medical documentation regarding the incident and injuries.

Please mail this completed FORM FDA 3649 

to the address to the right:

U.S. Food and Drug Administration 

Center for Devices and Radiological Health 

Document Mail Center – WO66-G609 

10903 New Hampshire Avenue 

Silver Spring, MD 20993-0002

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 2 hours per response, including the 

time to review instructions, search existing data sources, gather and maintain the data needed and complete 

and review the collection of information. Send comments regarding this burden estimate or any other aspect 

of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services 

Food and Drug Administration 

Office of Chief Information Officer 

Paperwork Reduction Act (PRA) Staff 

PRAStaff@fda.hhs.gov

“An agency may not conduct or sponsor, 

and a person is not required to respond to, a 

collection of information unless it displays a 

currently valid OMB number.”

FORM FDA 3649 (05/23) PAGE 5 of 5