Z-2411-2026Class II

Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model #...

Name: Z-2411-2026 Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model #...
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 MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat... 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-2411-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-18
Posted: 2026-06-16
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.
Product code: IZI System, X-Ray, Angiographic
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-2411-2026
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 IZI

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)