Medical device recalls High risk

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

Recall date
January 13, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1146-2025
FDA classification
Class I
Brand / firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold / distributed
Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombi…

Why it was recalled

Possibility of the patient falling from the table related to the mattress used on the patient table.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

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