GE OEC Medical Systems, Inc recalls GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures…

Recall date

September 15, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0841-2015

FDA classification

Class II

Brand / firm

GE OEC Medical Systems, Inc

Sold / distributed

Worldwide Distribution

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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