FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
- Recall number
- Z-1638-2015
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
- Status
- Terminated
- Initiated
- 2014-05-22
- Posted
- 2015-06-08
- Terminated
- 2015-06-24
- Reason
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- 9
- Distribution
- US Distribution to the states of: MD, NC, MT, NJ, UT and NY
- Lot, serial or model codes
- OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.
- 510(k) numbers
- ["K123603"]
- PMA numbers
- not on file
- Product code
- OXO
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28