CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used recalled
GE OEC Medical Systems is recalling GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications. The recall was initiated on 15 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0841-2015
- FDA event ID
- 69660
- Recalling firm
- GE OEC Medical Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2014
- FDA classified
- 12 Jan 2015
- Reported
- 21 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Surgical Instruments
Timeline
| 15 Sep 2014 | Recall initiated by company | |
| 12 Jan 2015 | Classified by FDA | +119 days |
| 21 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Where it was distributed
Worldwide Distribution
Questions about this recall
Is GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications recalled?
Yes. GE OEC Medical Systems recalled GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications on 15 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0841-2015.
Why was it recalled?
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
Which lots are affected?
GE OEC Brivo 865 Plus Serial Numbers: B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035 B4S13038 B4S13043 B4S13054 B4S13056 B4S13059- B4S13061 B4S14002- B4S14004 B4S14007 B4S14015 B4S14016 B4S14022 B4S14022 B4S1403 3 B4S1403 4
Where was it sold?
Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE OEC Medical Systems
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|---|---|---|---|---|---|
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| Device | CLASS II | OEC 3D recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite Systems with Image Intensifier recalled | GE OEC Medical Systems | Lead & Heavy Metals | Nationwide |
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