--- title: "Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078... — FDA record Z-2931-2026 | Is It on Recall" description: "Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complication" url: https://isitonrecall.com/recall/fda-device-z-2931-2026-philips-azurion-rystem-model-numbers-722063-722064-722067-722068-722078-722079-722221-722222-722223/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224,... — FDA record Z-2931-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jul 16, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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 - **Reason**: 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 - **Classification**: Class II - **Recalling firm**: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - **Quantity**: 10872 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2931-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2931-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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, 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[Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2931-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Report date**: Aug 19, 2026 - **Recall initiation date**: Jul 16, 2026 - **Center classification date**: Aug 10, 2026 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2931-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. records](https://isitonrecall.com/brand/philips-medical-systems-nederland-b-v/)