United StatesPhilips Azurion Rystem interventional fluoroscopic X‑ray systems (models 722063, 722064, 722067, 722068, 722078, 722079, 722221–722228, 722280–722282; software versions R2.2.10 and R2.1.10) are affected. The recall was issued because two software-related issues can cause degraded image quality (which may delay therapy, cause procedural complications, or inappropriate treatment) and loss of geometry movements (which may delay therapy and cause procedural complications).
What's being recalled
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
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
UDI: (01)00884838099258(21)1229, (01)00884838099258(21)450, (01)00884838085251(21)302, (01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)1578, (01)00884838099241(21)324, (01)00884838099241(21)585, (01)00884838099241(21)332, (01)00884838099258(21)750, (01)00884838099241(21)312, (01)00884838099241(21)85, (01)00884838099258(21)409, (01)00884838085268(21)1023, (01)00884838099272(21)125, (01)00884838099272(21)127, (01)00884838099272(21)126, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099258(21)295, (01)00884838099272(21)124, (01)00884838099272(21)120, (01)00884838099258(21)277, (01)00884838099258(21)262, (01)00884838099258(21)261, (01)00884838099258(21)272, (01)00884838099258(21)275, (01)00884838085367(21)547, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838085251(21)585, (01)00884838099258(21)1315, (01)00884838085268(21)645, (01)00884838085251(21)410, (01)00884838085268(21)646, (01)00884838099258(21)3526, (01)00884838099258(21)2744, (01)00884838099258(21)3698, (01)00884838099258(21)959, (01)00884838099258(21)381, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838099258(21)1371, (01)00884838099241(21)533, (01)00884838085268(21)1387, (01)00884838099272(21)153, (01)00884838099258(21)1019, (01)00884838085268(21)460, (01)00884838099258(21)260, (01)00884838085251(21)753, (01)00884838085268(21)35, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838099272(21)67, (01)00884838099258(21)1049, (01)00884838099258(21)3045, (01)00884838099258(21)3044, (01)00884838099258(21)3107, (01)00884838099258(21)2258, (01)00884838099258(21)1484, (01)00884838099272(21)209, (01)00884838099258(21)2573, (01)00884838099258(21)3514, (01)00884838099258(21)1083, (01)00884838099258(21)3314, (01)00884838085268(21)703307, (01)00884838099258(21)2436, (01)00884838099258(21)2184, (01)00884838099241(21)479, (01)00884838099272(21)271, (01)00884838099241(21)189…
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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada