Drug recall
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with…
FDA recall event 97359 · Class II · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Key facts
| Event ID | 97359 |
|---|---|
| Recall numbers | Z-2504-2025 |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Product type | Devices |
| Products | Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. |
| Initiation date | Aug 1, 2025 |
| Report date | Sep 10, 2025 |
| 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: