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: 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, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system |
| Quantity | 2016 units |
| Distribution | Worldwide distribution. |
| Initiated | 2026-07-16 |
| Classified | 2026-08-10 |
| Recall number | Z-2932-2026 |
| 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-2932-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99423/
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