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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 January 30, 2009
Date Posted September 25, 2009
Recall Status1 Terminated 3 on June 02, 2015
Recall Number Z-0937-2009
Recall Event ID 51488
Product Classification Ranging (Geodimeter) Laser Products - Product Code REQ
Product MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).
Code Information n/a
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		 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 Determined
Cause 2		 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
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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