The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2411-2026·Announced 2026-06-24

Philips MultiDiagnost Eleva hand switch buttons may not fully release

Philips MultiDiagnost Eleva systems are being recalled because the hand switch button may not fully release, potentially causing loss of imaging or unintended radiation exposure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a stated risk of unintended radiation exposure and additional contrast injection, a risk of harm with no injuries reported.

Plain-English summary

Philips MultiDiagnost Eleva systems are being recalled across the model numbers listed in the recall notice, including 708032, 708034 (with flat detector), 708036 and 708037. The recall applies to all codes.

The stated reason is that the hand switch button may not fully release, potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection. The FDA classified the action as Class II.

Distribution was in the United States and the rest of the world. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the model numbers in the recall notice and follow the instructions issued by Philips.

The recalled product

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 #…
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Fluoroscopy system
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All codes

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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