The Recall Desk
SevereFDA (Devices)·Z-1158-2025·Announced 2025-02-26

Philips Azurion 7 B20 imaging system patient fall hazard from table mattress

Philips Azurion 7 B20 imaging systems are recalled because the patient table mattress may allow patients to fall. This FDA Class I recall affects 1,314 units distributed worldwide.

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: This is classified as FDA Class I, which establishes a minimum severity level of Severe per the rubric. Although no actual injuries are reported in the source text, the hazard—patient falls from the medical imaging table—poses significant injury risk.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Azurion 7 B20 medical imaging system due to a defect with the mattress used on the patient table. The defect creates a possibility of the patient falling from the table during procedures. Three catalog numbers are affected: 722068, 722226, and 722236.

The recall covers 1,314 units distributed worldwide, including 270 in the United States and 1,044 in international markets. Affected facilities should verify whether they operate units matching the recalled serial numbers provided in the FDA notice. Healthcare providers using affected systems should be aware of the patient fall hazard.

The recalled product

Product
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
  • patient-fall
  • mattress-defect

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) 722068
  • (2) 722226
  • (3) 722236
  • UDI-DI: (1) 00884838085367
  • (2) 00884838099272
  • (3) 00884838116801
  • Serial Numbers: (1) 213
  • 407
  • 85
  • 89
  • 320
  • 73
  • 308
  • 288
  • 172
  • 295
  • 110
  • 406
  • 4444
  • 149

Distribution

Distributed nationwide across the United States.