FDA Medical Device Recalls (openFDA)
Flir Systems, Inc.: MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).
- Recall number
- Z-0937-2009
- Recalling firm
- Flir Systems, Inc.
- Product
- MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).
- Status
- Terminated
- Initiated
- 2009-01-30
- Posted
- 2009-09-25
- Terminated
- 2015-06-02
- Reason
- LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Customers will be notified by a letter instructing them to stop using the LRF, contact a Customer Service Representative, and to detach and return the Laser Range Finder. For each returned LRF, FLIR will provide a certified Class I LRF.
- Quantity
- 120
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- n/a
- 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