Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1223-2009 · Posted 2009-09-25

Recalling FirmFlir Systems, Inc.
Recall StatusTerminated
Product CodeREQ
Date Initiated2009-03-10
Date Terminated2015-05-28
Product Quantity58

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution -- Washington, D.C.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑