The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1145-2025·Announced 2025-02-26

Philips Allura Xper FD20 Biplane Patient Fall Risk Recall

Philips Allura Xper FD20 Biplane x-ray tables are being recalled due to a mattress defect that could cause patients to fall. The recall affects 479 units distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as Severe (score 4). The FDA designated this as a Class I recall, which mandates a minimum severity score of 4. While no actual injuries or deaths have been reported in the source text, the hazard of patient falls from medical equipment represents a significant safety risk to patients.

Plain-English summary

The Allura Xper FD20 Biplane is an x-ray imaging system manufactured by Philips Medical Systems Nederland B.V. The system is being recalled by the FDA (Class I) due to a safety hazard affecting the patient table.

The patient table mattress poses a risk of patients falling from the table during use. This hazard could result in patient injury.

The recall affects 479 units distributed worldwide: 186 in the United States and 293 internationally across more than 100 countries. Two catalog numbers are affected (722008 and 722013), with specific serial numbers listed in the FDA notice.

The recalled product

Product
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — X-ray Imaging 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 (20)

  • Catalog numbers: (1) 722008
  • (2) 722013
  • UDI-DI: (1) No UDI
  • (2) 00884838059061
  • Serial Numbers: (1) 491
  • 489
  • 360
  • 325
  • 142
  • 312
  • 319
  • 516
  • 244
  • 453
  • 306
  • 378
  • 124
  • 18270
  • 524
  • 463

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 →

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