Recall Z-1638-2015 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
| Date | Jun 8, 2015 (initiated May 22, 2014) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME Ge Healthcare Surgery GE Oec Medical Systems, Inc., May 17, 2013 |