Recall Z-2626-2025— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-2626-2025
Creator: U.S. Food and Drug Administration
Published: 2025-09-03

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-09-03. It names 6 FDA 510(k) clearances: K161563, K141979, K133292 and 3 more. Product: Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;. Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-03
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

6 on FDA's record

K161563 — Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.·cleared 2016-07-29
K141979 — ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIESPhilips Medical Systems Netherland BV·cleared 2014-08-19
K133292 — ALLURA XPER FD; OR TABLEPhilips Medical Systems Nederland B.V.·cleared 2014-03-05
K130638 — ALLURACLARITY XPER FD SERIES X-RAY SYSTEMPhilips Medical Systems Nederland B.V.·cleared 2013-06-28
K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESPhilips Medical Systems Nederland B.V.·cleared 2013-05-21
K102005 — ALLURA XPER OR TABLE SERIESPhilips Medical Systems North America, Inc.·cleared 2010-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Reason for recall

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

Data sourced from openFDA. This site is unofficial and independent of the FDA.