GE OEC Medical Systems, Inc: Medical Device Recall in 2015 - (Recall #: Z-0840-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 15, 2014

Date Posted: January 21, 2015

Recall Number: Z-0840-2015

Event ID: 69660

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).

Status: Terminated

Product Quantity: 61 units installed in US

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

Voluntary or Mandated:

Voluntary: Firm initiated