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FDA (Device enforcement)Recalled 2025-01-13class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

Hazard

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

Details from the source

Reason for recall: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel Distribution: Worldwide distribution - US Nationwide and the countries of Canada, 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, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Repub Quantity: 251 units US; 938 units OUS Lot/code info: UDI: (1) 722068 00884838085367(21); (2) 722226 00884838099272(21); (3) 722236 00884838116801(21)

UPC codes

00884838085367, 00884838099272, 00884838116801

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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