Brilliance iCT - Computed Tomography X-ray systems recalled over fire hazard

Recall date

July 11, 2017

Source

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

Official notice title

Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT - Model 728306 Computed Tomography X-ray systems

Recall number

Z-0403-2018

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide distribution, including US nationwide.

Why it was recalled

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

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 iCT - Model 728306 Computed Tomography X-ray systems