Class II — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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 |
| 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 |
| Quantity | 10872 units |
| Distribution | Worldwide |
| Initiated | 2026-07-16 |
| Classified | 2026-08-10 |
| Recall number | Z-2931-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (Z-2931-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99422/
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