Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer

Recalled June 3, 2015 · FDA recall Z-1656-2015 · Philips Medical Systems (Cleveland)

Hazard

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. · FDA Class II

Units

153 units total

Sold at

Distributed in China.

Description

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Product

Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →