MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF).

FDA device recall Z-0937-2009 · posted 2009-09-25 · Terminated

Recall details

Recalling firm

Flir Systems, Inc.

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

REQ

Quantity affected

120

Distribution

Nationwide Distribution

Date initiated

2009-01-30

Date posted

2009-09-25

Date terminated

2015-06-02

Location

North Billerica, MA