Potential for temporary loss of imaging (X-ray) functionality due to software issue.
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
00884838054189, 00884838054196
Official record: FDA (Device enforcement) ↗
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