GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
FDA device recall Z-1638-2015 · posted 2015-06-08 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- 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.
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 9
- Distribution
- US Distribution to the states of: MD, NC, MT, NJ, UT and NY
- Date initiated
- 2014-05-22
- Date posted
- 2015-06-08
- Date terminated
- 2015-06-24
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME (K123603) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013-05-17 |