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Recall Observatory FDA recall evidence

Device product

GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

Z-0840-2015

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-0840-2015

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 715 Prime Serial Numbers: B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6

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).