The Recall Desk
HighFDA (Devices)·Z-2412-2026·Announced 2026-06-24

Philips Allura Xper hand switch buttons may not fully release

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

What this means for you

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 Allura Xper systems are being recalled across the model numbers listed in the recall notice, including 722001 (Allura Xper FD10C), 722002 (FD10F), 722003 (FD10), 722005 (FD10/10), 722006 (FD20) and 722008 (FD20 Biplane), together with MultiDiagnost Eleva systems. 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 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
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional X-ray 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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