Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model
FDA device recall Z-2504-2025 · posted 2025-09-03 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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.
- Action taken
- Philips began notifying consignees on about 08/01/2025 via letter. Consignees were instructed to notify all applicable personnel, notify customers if the units have been transferred or distributed, maintain the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system, and to complete and return the response form. Philips will be inspecting affected Nehalem Flexvision-2 PCs and installing the air baffle if it is confirmed that this component is missing. Philips expects to start the implementation of this action in affected devices by Q4 2025. Your local Philips representative will contact you to schedule a visit to perform this activity in your system once available.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 192 untis
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentin
- Date initiated
- 2025-08-01
- Date posted
- 2025-09-03
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979) | Philips Medical Systems Netherland BV | 2014-08-19 |
| ALLURA XPER FD; OR TABLE (K133292) | Philips Medical Systems Nederland B.V. | 2014-03-05 |
| ALLURACLARITY XPER FD SERIES X-RAY SYSTEM (K130638) | Philips Medical Systems Nederland B.V. | 2013-06-28 |
| ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842) | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| ALLURA XPER OR TABLE SERIES (K102005) | Philips Medical Systems North America, Inc. | 2010-08-09 |