Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscop
FDA device recall Z-2928-2026 · posted 2026-08-10 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- Firmware issue potentially leading to loss of geometry movements.
- Action taken
- Philips notified consignees on about 06/29/2026 via certified mailed letter titled URGENT Medical Device Correction. Consignees were provided instructions to properly identify affected systems and table configurations, instructions for restarting the geometry when the issue occurs, to ensure the notification is distributed to all relevant users and retained with device documentation until corrective actions are completed. Consignees were also instructed to post the notification letter near affected devices for ease of reviewing, notify recipients if affected units were transferred, and to complete and return the provided response form. A Local Philips representative will contact consignees to schedule a visit for the implementation of the software update once available. Philips will address the identified issues by implementing a software update (R8.2.102.1) in all affected systems (FCO72200674). Philips currently expects R8.2.102.1 to be available by Q1 2027, subject to regulatory clearance.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 4,252 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia,
- Date initiated
- 2026-06-29
- Date posted
- 2026-08-10
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Allura Xper FD series and Allura Xper OR Table series (K162859) | Philips Medical Systems Nederland B.V. | 2016-12-02 |
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| 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 |