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Recall Observatory FDA recall evidence

Device 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

Z-0654-2013

January 21, 2010

Class II

Product summary

Firm
Lockheed Martin Gyrocam Systems, Inc.
Event
Event 64029
Status
Terminated
Classification
Class II
Quantity
33 units
Official record key
device-enforcement:Z-0654-2013

Official wording

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.

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.

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.