PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, intervention

Hazard

Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

Details from the source

Reason for recall: Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Quantity: 3011 units Lot/code info: Model /UDI-DI: (1) 722063 (01)00884838085275(21); (2) 722064 (01)00884838085282(21); (3) 722067 (01)00884838085350(21); (4) 722068 (01)00884838085367(21); (5) 722078 (01)00884838085251(21); (6) 722079 (01)00884838085268(21). Software Version Number: R1.0, R1.1, R1.2

UPC codes

00884838085275, 00884838085282, 00884838085350, 00884838085367, 00884838085251, 00884838085268

Source

Official record: FDA (Device enforcement) ↗

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