FDA Medical Device Recalls (openFDA)
Flir Systems, Inc.: MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer
- Recall number
- Z-1223-2009
- Recalling firm
- Flir Systems, Inc.
- Product
- MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer
- Status
- Terminated
- Initiated
- 2009-03-10
- Posted
- 2009-09-25
- Terminated
- 2015-05-28
- Reason
- MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- FLIR Systems notified direct account by letter of the Corrective Action Plan and updated certification label that references CDRH issued variance and instructions on how to install it.
- Quantity
- 58
- Distribution
- Nationwide Distribution -- Washington, D.C.
- Lot, serial or model codes
- Serial numbers: AH0260 AH0264 AH0259 AH0257 AH0250 AH0261 AH0258 AH0467 AH0413 AH0414 AH0415 AH0416 AH0417 AH0450 AH0451 AH0456 AH0458 AH0459 AH0460 AH0462 AH0464 AH0465 AH0461 AH0453 AH0454 AH0452 AH0455 AH0457 AH0463 AH0414 AH0466 AH0468 AH0599 AH0600 AH0606 AH0601 AH0608 AH0597 AH0596 AH0602 AH0470 AH0595 AH0607 AH0471 AH0603 AH0469 AH0609 AH0598 AH0604 AH0605 AH0610 AH0613 AH0611 AH0612, and AH0614.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REQ
- Firm FEI
- 1220474
- Firm city
- North Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28