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
USPhilips 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.
Reason for Recall / 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
Product Description & Identification
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 Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| Event id | 99422 |
| Address 1 | Veenpluis 6 |
| Code info | 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)00884838099... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 10872 units |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260716 |
| Initial firm notification | Letter |
| Center classification date | 20260810 |
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Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide
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🚨 SAFETY ALERT: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - 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 Check if your household is affected: https://therecallfile.com/recalls/philips-azurion-rystem-model-numbers-722063-722064-722067-722068-72207/FDA-Z-2931-2026
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