The Recall Desk
HighFDA (Devices)·Z-1647-2023·Announced 2023-06-07

Philips Azurion X-ray Systems May Lose Imaging Capability When Storage Full

Philips Azurion X-ray imaging systems may suddenly lose X-ray functionality when disk storage capacity is reached, potentially interrupting medical procedures.

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 no reported illnesses or injuries. Equipment failure—loss of X-ray imaging when disk capacity becomes full—represents a risk-of-harm scenario in clinical settings where procedure interruption could affect patient care.

Plain-English summary

Philips Azurion X-ray imaging systems with software versions R2.2.0, R2.2.1, R2.2.3, R2.2.5, and R2.2.6 are subject to this recall. When the system's disk storage reaches full capacity, X-ray functionality ceases and users experience a sudden interruption of the imaging procedure.

This recall affects 1,063 systems distributed in the United States and 2,136 systems distributed internationally across multiple countries. Affected models include Azurion 3M12, 3M15, SM12, SM20, 7B12/12, 7820/15, 7M12, and 7M20.

If you operate an affected Philips Azurion system, contact Philips Medical Systems Nederland B.V. for guidance on remediation. Philips is responsible for addressing this defect in accordance with FDA Class II requirements.

The recalled product

Product
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6)
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Imaging Equipment
Hazard
  • loss-of-imaging-function
  • equipment-malfunction

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 (9)

  • (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21)
  • (3) Azurion SM12: 722227 (01)00884838099227(21)
  • (4) Azurion SM20: 722228 (01)00884838099234(21)
  • (7) Azurion 7M12: 722078 (01)00884838085251(21) 722223 (01)00884838099241(21)
  • (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21)
  • Software: R2.2.O
  • R2.2.1
  • R2.2.3
  • R2.2.5 and R2.2.6

Distribution

Distributed nationwide across the United States.

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