Z-0654-2013 Class II Terminated
FDA device recall Z-0654-2013 was initiated by Lockheed Martin Gyrocam Systems, Inc. on January 21, 2010 and is designated Class II. 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, le… The recall status is terminated (terminated February 24, 2015). Affected quantity: 33 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2013
- Initiation Date
- January 21, 2010
- Termination Date
- February 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
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.
Distribution Pattern
Nationwide Distribution
Code Information
Gyrocam DNV Camera System, Serial Numbers: 137, 138, 141, 142, 143, 144, 145, 148, 150, 151, 152, 158, 159, 160, 164, 165, 170, 172, 173, 174, 175, 177; Gyrocam DS Camera System, Serial Numbers: 134, 140, 147, 153, 169, 181; Gyrocam TS Camera System, Serial Numbers: 132, 146, 149, 171, 502.