The Recall Desk
HighFDA (Devices)·Z-0886-2022·Announced 2022-05-11

Azurion Medical Imaging System Software Defect Alters Dose Parameters

A software defect in Philips Azurion imaging systems causes the Patient Type to change unexpectedly during study initiation, altering dose control parameters without operator notification.

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 medical device recall involving a software defect that can apply incorrect dose control parameters without operator notification. No illnesses or injuries have been reported, meeting the criteria for High severity (risk-of-harm product with no reported injury).

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling Azurion systems with software release R1.x due to a software defect affecting dose control. Approximately 722 units have been distributed nationwide and worldwide.

The defect occurs in the "Add Study" function. When a user selects a Patient Type and initiates the study by pressing "Start Procedure," the software inadvertently changes the Patient Type to a different option without notifying the operator. Since Patient Type is a factor in the dose control process, this unannounced change causes the system to apply incorrect technique factors without user awareness.

The recalled product

Product
Azurion systems with software release R1.x
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device
Hazard
  • software-defect
  • dose-control-error
  • unnotified-change

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 (1)

  • software release R1.x

Distribution

Distributed nationwide across the United States.

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