Reported Oct 19, 2016 · Terminated
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray…
GE OEC Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE OEC Medical Systems, Inc · 384 N Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
OEC Brivo 715 PrimeOEC Brivo 785 Essential
- OEC Brivo 865 Advance Product UsageThe OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use
- Lot codes and dates
23 of 23 products
Products covered by this recall # Product as published 1 Serial Numbers B2S15158 to B2S15164 2 B2S15166 to B2S15171 3 B2S15173 to B2S15195 4 B2S15197 5 B2S15200 6 B2S15202 7 B2S16046 8 B2S16050 9 B2S16051 GE Brivo OEC785: Serial Numbers B3S15236 10 B3S15241 11 B3S15242 12 B3S15246 13 B3S15248 14 B3S15250 15 B3S15253 to B3S15257 16 B3S15259 to B3S15338 17 B3S15353 18 B3S15357 to B3S15359 19 B3S16152 GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070 20 B4S15072 - Amount recalled
- 148 total
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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