Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.

Recalled July 6, 2016 · FDA recall Z-2112-2016 · Philips Medical Systems (Cleveland)

Hazard

Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack. · FDA Class II

Units

1 unit

Sold at

Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Description

Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.

Product

Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

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