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Recall Observatory FDA recall evidence

Device product

GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

Z-0841-2015

September 15, 2014

Class II

Product summary

Firm
GE OEC Medical Systems, Inc
Event
Event 69660
Status
Terminated
Classification
Class II
Quantity
61 units installed in US
Official record key
device-enforcement:Z-0841-2015

Official wording

Reason: 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).

Code information: 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

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).