Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The hazard
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: (01)00884838099258(21)1229Model (01)00884838099258(21)450Model (01)00884838085251(21)302Model (01)00884838099258(21)1576Model (01)00884838099258(21)1577Model (01)00884838099258(21)1578Model (01)00884838099241(21)324Model (01)00884838099241(21)585Model (01)00884838099241(21)332Model (01)00884838099258(21)750Model (01)00884838099241(21)312Model (01)00884838099241(21)85Model (01)00884838099258(21)409Model (01)00884838085268(21)1023Model (01)00884838099272(21)125Model (01)00884838099272(21)127Model (01)00884838099272(21)126Model (01)00884838099272(21)122Model (01)00884838099272(21)123Model (01)00884838099258(21)295Model (01)00884838099272(21)124Model (01)00884838099272(21)120Model (01)00884838099258(21)277Model (01)00884838099258(21)262Model (01)00884838099258(21)261UPC 00884838099258UPC 00884838085251UPC 00884838099241UPC 00884838085268UPC 00884838099272Would you have heard about this one?
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