Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0937-2009

MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding...

Flir Systems / initiated 2009-01-30 / Terminated

Flir Systems, Inc. began a recall of MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF) on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0937-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Flir Systems
Product
MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).
Product code
REQ Laser Rangefinders, Time-Of-Flight Speed Measurement Products
Reason for recall
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.
FDA 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 in commerce
120
Distribution
Nationwide Distribution
Product codes and lots
n/a