The Recall Desk
SevereFDA (Devices)·Z-1148-2025·Announced 2025-02-26

Philips Allura Xper FD20/10 Imaging System Patient Table Mattress Fall Risk

Philips is recalling the Allura Xper FD20/10 imaging system due to a defect in the patient table mattress that could allow patients to fall during procedures. The Class I recall affects 87 units distributed globally, including 22 in the US.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, establishing a minimum severity score of 4 per the rubric. The source does not report any injuries or deaths, so the classification does not meet the threshold for a higher score.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20/10 imaging system (catalog number 722029) due to a mattress defect on the patient table. The defect creates a possibility that patients could fall from the table during procedures.

The FDA has classified this as a Class I recall. It affects 87 units total: 22 in the United States and 65 distributed to healthcare facilities in more than 80 countries.

Healthcare facilities using this equipment should contact Philips Medical Systems for guidance on the appropriate course of action. Refer to FDA recall notice Z-1148-2025 for additional details.

The recalled product

Product
Allura Xper FD20/10; Catalog numbers: 722029
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Diagnostic Imaging
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 (20)

  • Catalog number: 722029
  • UDI-DI: 00884838054219
  • Serial Numbers: 71
  • 91
  • 7
  • 94
  • 62
  • 88
  • 36
  • 97
  • 21
  • 100
  • 30
  • 63
  • 60
  • 129
  • 84
  • 95
  • 126
  • 110

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 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 20 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · fall risk

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