The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1159-2025·Announced 2025-02-26

Azurion 7 M12 Patient Tables: Fall Risk from Defective Mattress

Philips Azurion 7 M12 patient tables are recalled due to a mattress defect that could cause patients to fall. Approximately 1,837 units are affected globally.

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 is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. The mattress defect on a patient table presents a structural hazard—a fall risk—that could result in serious patient injury in a medical setting.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Azurion 7 M12 patient table system. The affected models have catalog numbers 722078, 722223, and 722233, with 722233 distributed outside the United States only.

The recall is due to a defect in the mattress used on the patient table. The mattress defect creates a possibility that patients could fall from the table during medical procedures.

Approximately 1,837 units have been distributed globally, including 337 units in the United States and 1,500 units in countries outside the US. Healthcare providers using this equipment should discontinue use and contact Philips Medical Systems Nederland B.V. for instructions on corrective action or replacement.

The recalled product

Product
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Patient Table / Imaging Equipment
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) 722078
  • (2) 722223
  • (3) 722233 (OUS ONLY)
  • UDI-DI: (1) 00884838085251
  • (2) 00884838099241
  • (3) 00884838116764
  • Serial Numbers: (1) 465
  • 437
  • 438
  • 143
  • 302
  • 559
  • 170
  • 824
  • 626
  • 697
  • 278
  • 491
  • 215
  • 720

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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