Drug recall
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions…
FDA recall event 98096 · Class II · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Key facts
| Event ID | 98096 |
|---|---|
| Recall numbers | Z-1091-2026 |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Product type | Devices |
| Products | Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart… |
| Initiation date | Dec 12, 2025 |
| Report date | Jan 21, 2026 |
| City | Best |
| Country | Netherlands |
| FEI number | 3002807880 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: