Reported Aug 19, 2026 · Ongoing · Updated Sep 6, 2026
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224,…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 6 · Best · N/A
Is this the product you have?
- Philips Azurion Rystem
- Model Numbers722063, 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
- Lot codes and dates
- UDI
1,192 of 1,192 codes
(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
- UDI
- Amount recalled
- 10872 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Medical Systems Nederland B.v. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.