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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