Philips Medical Systems (Cleveland) Inc recalls Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

Recall date

June 21, 2016

Source

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

Recall number

Z-2111-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

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

Why it was recalled

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 and cause injury to patients, operators, by standers or service personnel.

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

What was recalled

Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.