Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128, model #728323; 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-2114-2016

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 causing injury to patients, operators, by-standers and 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

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.