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U.S. Department of Health and Human Services

Class 2 Device Recall MilCAM Recon III

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  Class 2 Device Recall MilCAM Recon III see related information
Date Initiated by Firm March 10, 2009
Date Posted September 25, 2009
Recall Status1 Terminated 3 on May 28, 2015
Recall Number Z-1223-2009
Recall Event ID 51867
Product Classification Ranging (Geodimeter) Laser Products - Product Code REQ
Product MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer
Code Information 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.
Recalling Firm/
Manufacturer		 Flir Systems, Inc.
25 ESQUIRE RD
North Billerica MA 01862-2501
For Additional Information Contact
978-670-5555
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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