Medical Device
Manufacturing
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Z-0654-2013Class II

Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law...

Lockheed Martin Gyrocam Systems, Inc. / initiated 2010-01-21 / Terminated / root cause: manufacturing process

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
FDA enforcement reports joined to recall event Z-0654-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0654-2013Class IITerminatedVoluntary: Firm initiated