Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1223-2009

MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer

Flir Systems / initiated 2009-03-10 / Terminated

Flir Systems, Inc. began a recall of MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1223-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Flir Systems
Product
MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer
Product code
REQ Laser Rangefinders, Time-Of-Flight Speed Measurement Products
Reason for recall
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.
FDA 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 in commerce
58
Distribution
Nationwide Distribution -- Washington, D.C.
Product codes and lots
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.