FDA Recall
Terminated
MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).
Recall: Z-0937-2009
·
Initiated January 30, 2009
Recall
- Recall Number
- Z-0937-2009
- Event Number
- 51488
- Firm
- Flir Systems, Inc.
- FEI Number
- 1220474
- Product Code
- REQ
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- January 30, 2009
- Posted
- September 25, 2009
- Terminated
- June 2, 2015
- Address
- 25 ESQUIRE RD, North Billerica, MA, 01862-2501
Description
MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).
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.
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.
Distribution
Nationwide Distribution
Quantity
120