Recall Z-2189-2025— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-2189-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-30

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-06-30. It names 4 FDA 510(k) clearances: K162859, K161563, K141979 and 1 more. Product: Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.. Reason: Potential for temporary loss of imaging (X-ray) functionality due to software issue..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-30
Firm location: Best, Netherlands

510(k) clearances named in this recall

4 on FDA's record

K162859 — Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.·cleared 2016-12-02
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

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

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

Reason for recall

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

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