MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer
FDA device recall Z-1223-2009 · posted 2009-09-25 · Terminated
Recall details
- Recalling firm
- Flir Systems, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- REQ
- Quantity affected
- 58
- Distribution
- Nationwide Distribution -- Washington, D.C.
- Date initiated
- 2009-03-10
- Date posted
- 2009-09-25
- Date terminated
- 2015-05-28
- Location
- North Billerica, MA
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