Medical device recalls Moderate risk

Philips North America Llc recalls Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Recall date
April 1, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1660-2025
FDA classification
Class II
Brand / firm
Philips North America Llc
Sold / distributed
Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg,…

Why it was recalled

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

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 CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

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