Philips Medical Systems (Cleveland) Inc recalls Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The pro…

Recall date

April 25, 2006

Source

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

Recall number

Z-0400-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide distribution, including US states of CA and NV.

Why it was recalled

Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.

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 (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.