The Recall Desk
HighFDA (Devices)·Z-2403-2023·Announced 2023-09-13

Azurion imaging systems recalled for stuck foot switch causing unintended radiation

Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.

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 a medical device recall with a specific hazard (unintended radiation emission) that poses a genuine risk of harm. However, no illnesses or injuries are reported in the source, and the device is FDA Class II rather than Class I. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a score of 3 (High).

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Azurion imaging system. Approximately 5,432 systems have been distributed nationwide in the United States.

A fault in the foot switch pedal can cause it to stick in the active position when released by the user. When this occurs, unintended radiation is emitted from the device. This malfunction creates a risk of unintended radiation exposure.

Healthcare facilities nationwide that use Azurion systems may be affected by this recall.

Affected facilities should stop using the device immediately and contact Philips for technical guidance and instructions on remediation or replacement.

The recalled product

Product
Azurion
Manufacturer
Philips Medical Systems Nederland B.V.
Category
Medical Device — Imaging System
Hazard
  • unintended-radiation
  • device-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 (1)

  • Azurion series

Distribution

Distributed nationwide across the United States.

Related recalls

Same category