Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law...
Lockheed Martin Gyrocam Systems, Inc. began a recall of Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0654-2013
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Lockheed Martin Gyrocam Systems, Inc.
- 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
- Product code
- REX Ir Laser Illuminator Only/Night Vision System
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Radiation Control for Health and Safety Act
- 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
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0654-2013 | Class II | Terminated | Voluntary: Firm initiated |
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