OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Prod
FDA device recall Z-0071-2017 · posted 2016-10-11 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated September 23, 2016 to customers. The letter informed customers of the affected product, safety issue, and safety instructions for immediate mitigation of the issue. GE Healthcare will correct all affected products at no cost to customers. A GE Healthcare representative will the customers to arrange for the correction. Please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 148 total
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.
- Date initiated
- 2016-09-23
- Date posted
- 2016-10-11
- Date terminated
- 2017-04-24
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |