CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report

Philips MultiDiagnost Eleva with the following recalled

Philips Medical Systems Nederl is recalling Philips MultiDiagnost Eleva with the following. The recall was initiated on 18 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll codes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2411-2026
FDA event ID: 99223
Recalling firm: Philips Medical Systems Nederl, Best
Classification: Class II
Status: Ongoing
Recall initiated: 18 May 2026
FDA classified: 16 Jun 2026
Reported: 24 Jun 2026
Type: FDA Mandated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 May 2026	Recall initiated by company
16 Jun 2026	Classified by FDA	+29 days
24 Jun 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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.

Where it was distributed

US and ROW.

Questions about this recall

Why was it recalled?

Which lots are affected?

All codes

Where was it sold?

US and ROW.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99223

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026	CLASS II	Philips Allura Xper with the following recalled	Philips Medical Systems Nederl	Other

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