Recall Z-1071-2026— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-1071-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-15

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-12-15. It names 6 FDA 510(k) clearances: K161563, K141979, K133292 and 3 more. Product: Allura Xper FD20 Biplane; Model Number: 722013;. Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-15
Firm location: Best, 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 Biplane; Model Number: 722013;

Reason for recall

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

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