PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280

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: 42 units US; 661 units OUS Lot/code info: UDI: (1) 722064 00884838085282(21); (2) 722222 00884838099210(21); (3) 722280 00884838103276(21)

UPC codes

00884838085282, 00884838099210, 00884838103276

Source

Official record: FDA (Device enforcement) ↗

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