The Recall Desk
HighFDA (Devices)·Z-0734-2022·Announced 2022-03-30

Azurion Medical Imaging System Software Defect Affects Patient Dose Control

Philips Azurion R2.1 systems have a software defect that causes the Patient Type to change unexpectedly when starting a procedure, potentially affecting dose control settings without user 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: This is an FDA Class II medical device recall involving a software defect in a dose control system. However, the source text does not report any illnesses, injuries, or deaths. The hazard is theoretical—the risk of incorrect dosing through unintended patient type changes has not resulted in reported harm. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3 (High).

Plain-English summary

Philips Healthcare is recalling Azurion medical imaging systems with software release R2.0.x (model Azurion R2.1) due to a software defect affecting patient type selection. Approximately 69 systems have been distributed nationwide across the United States.

The defect occurs when users initiate a study. When a user selects a specific Patient Type in the Add Study dialogue and then presses Start Procedure, the software unexpectedly changes the Patient Type to a different type than what was selected. This change happens without notification to the user.

Patient Type is a factor in the dose control process. The unintended change in Patient Type alters the technique factors used by the system, potentially resulting in incorrect dose control settings for the imaging procedure.

Affected healthcare facilities and physicians should contact Philips Healthcare for instructions on updating to corrected software. Users should verify that the correct Patient Type is applied before proceeding with imaging studies.

The recalled product

Product
Azurion systems with software release R2.0.x
Manufacturer
Philips Healthcare
Category
Medical Device — Medical Imaging
Hazard
  • software-defect
  • dose-control-error
  • patient-type-mismatch

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)

  • Model(s) Azurion R2.1

Distribution

Distributed nationwide across the United States.

Related recalls

Same category