PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233

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: 1346 units US; 2582 units Lot/code info: UDI: (1) 722224 00884838099258(21); (2) 722079 00884838085268(21); (3) 722234 00884838116771(21); (4) 722282 00884838110571(21)

UPC codes

00884838099258, 00884838085268, 00884838116771, 00884838110571

Source

Official record: FDA (Device enforcement) ↗

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