Recall Z-0654-2013— Lockheed Martin Gyrocam Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Lockheed Martin Gyrocam Systems, Inc., initiated 2010-01-21, terminated 2015-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS. Reason: These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system..
- Recalling firm
- Lockheed Martin Gyrocam Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-01-21
- Terminated
- 2015-02-24
- Firm location
- Sarasota, FL, United States
Product description
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
Reason for recall
These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.