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FDA (Device enforcement)Recalled 2025-06-30class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper

Hazard

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

Details from the source

Reason for recall: Potential for temporary loss of imaging (X-ray) functionality due to software issue. Distribution: Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Quantity: 4,508 units Lot/code info: Software Verion: R8.2.x. Model Number [UDI Numbers]: 1. 722026 [(01)00884838054189(21)765, (01)00884838054189(21)156, (01)00884838054189(21)253, (01)00884838054189(21)287, (01)00884838054189(21)825, (01)00884838054189(21)394, (01)00884838054189(21)713, (01)00884838054189(21)465, (01)00884838054189(21)74, (01)00884838054189(21)462, (01)00884838054189(21)192, (01)00884838054189(21)191, (01)00884838054189(21)522, (01)00884838054189(21)204, (01)00884838054189(21)155, (01)00884838054189(21)1132, (01)00884838054189(21)967, (01)00884838054189(21)205, (01)00884838054189(21)1246, (01)00884838054189(21)122, (01)00884838054189(21)259, (01)00884838054189(21)185, (01)00884838054189(21)618, (01)00884838054189(21)531, (01)00884838054189(21)855, (01)00884838054189(21)235, (01)00884838054189(21)805, (01)00884838054189(21)725, (01)00884838054189(21)832, (01)00884838054189(21)368, (01)00884838054189(21)646, (01)00884838054189(21)653, (01)00884838054189(21)663, (01)00884838054189(21)965, (01)00884838054189(21)258, (01)00884838054189(21)602, (01)00884838054189(21)908, (01)00884838054189(21)959, (01)00884838054189(21)221, (01)00884838054189(21)1129, (01)00884838054189(21)973, (01)00884838054189(21)664, (01)00884838054189(21)778, (01)00884838054189(21)109, (01)00884838054189(21)110, (01)00884838054189(21)116, (01)00884838054189(21)512, (01)00884838054189(21)115, (01)00884838054189(21)284, (01)00884838054189(21)389, (01)00884838054189(21)841, (01)00884838054189(21)223, (01)00884838054189(21)694, (01

UPC codes

00884838054189, 00884838054196

Source

Official record: FDA (Device enforcement)

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

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