Z-2412-2026Class II

Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002...

Name: Z-2412-2026 Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002...
Creator: Philips Medical Systems Nederland B.v.
Published: 2026-05-18
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2026-05-18 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura... on 2026-05-18. FDA classified it as Class II and gives the reason as "Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2412-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-18
Posted: 2026-06-16
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips will send a customer notification dated May 18, 2026 to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and replace the hand switch with a new design hand switch.
Distribution: US and ROW.
Product codes and lots: All codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2412-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2411-2026	Class II	Ongoing	FDA Mandated	2026-06-24	2026-06-16
Z-2412-2026	Class II	Ongoing	FDA Mandated	2026-06-24	2026-06-16

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)