Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbe
FDA device recall Z-2891-2026 · posted 2026-08-05 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
- Action taken
- Philips notified consignees on about 06/17/2026 via letter sent certified mail titled, URGENT Medical Device Correction. Consignees were instructed to circulate the notification letter to all users of the system for awareness and to follow the instructions. In the case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available for ceiling-mounted systems with the FlexMove option. For floor-mounted systems, only rotational (3) stand movements remain available. The table longitudinal position (4) can be adjusted manually, when the table is not tilted. Additionally, consignees were instructed to provide a copy of the notification letter to any organizations to which affected units have been transferred to, to keep the notification letter with system documentation until the correction is complete and complete and return the provided response form. Philips will inspect all affected systems and replace HDDs that are not according to the specifications, as well as correct configurations where different HDD types are used within a single system. Philips expects to start the implementation of this correction in September 2026.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 5,012 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-06-17
- Date posted
- 2026-08-05
- 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 |