| | Class 2 Recall
Lockheed Martin Gyrocam Systems ( LMGS |  |
| Date Posted |
February 14, 2013 |
| Recall Number |
Z-0654-2013 |
| Product |
Lockheed Martin Gyrocam Systems ( LMGS)
LMGS 15" camera systems Laser pointer and illuminator used for law enforcement surveillance from aircraft. |
| Code Information |
Models DNV TS and DS
|
Recalling Firm/
Manufacturer |
Lockheed Martin Gyrocam Systems, Inc.
7345 16th St E Bldg C-101
Manatee County
Sarasota, Florida 34243-6808 |
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.
|
| Action |
Please note that LMGS is responsible for the correction of all noncompliant products.
1. Notifications to all purchasers must be made, and the FDA district office Recall Coordinator is to be included in the notifications.
2. Correction of all units to be completed by November 8, 2013.
3. All products will be brought into compliance with the laser performance standard at no cost to the purchaser.
4. LMGS will submit a product report for the new camera system prior to installation of the replacement lasers as per 21 CFR 1002.10 and certify that the new camera systems comply with the general performance standard in 21 CFR 1010 and the laser performance standard found in 21 CFR 1040.10 and 1040.11
5. Updated operator manuals will be provided to purchasers.
Further questions please call (941) 355-3206. |
| Quantity in Commerce |
33 units |
| Distribution |
Nationwide Distribution |
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