Medical device recalls Moderate risk

Philips North America, LLC recalls Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

Recall date
April 6, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1922-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
Worldwide distribution including one unit distributed to Iowa.

Why it was recalled

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

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

What was recalled

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

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