Recall Z-1638-2015
GE OEC Medical Systems, Inc · initiated May 22, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Codes / lots: OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.
Reason for recall
Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
GE Healthcare Surgery Planned Action(s) to repair the defect or to bring the product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 9 units consisted of the following: 1. Replacing the tube side cover with the laser aimer assembly with a tube side cover without a laser aimer assembly. This correction brought the systems into compliance with applicable US regulations. For further questions please call (801) 536-4615.
Details
- Recall number
- Z-1638-2015
- Initiated
- May 22, 2014
- Posted by FDA
- June 8, 2015
- Terminated
- June 24, 2015
- Product code
- OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
- Quantity
- 9
- Distribution
- US Distribution to the states of: MD, NC, MT, NJ, UT and NY
- Recalling firm
- GE OEC Medical Systems, Inc, Salt Lake City, UT