The Recall Desk
HighFDA (Devices)·Z-2402-2023·Announced 2023-09-13

Philips Allura Xper X-ray Systems Foot Pedal May Stick, Causing Unintended Radiation

Philips Allura Xper X-ray imaging systems are being recalled because the foot switch pedal may become stuck in the active position, potentially causing unintended radiation emission. The recall affects 5,432 systems distributed nationwide.

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 involving a risk-of-harm product (unintended radiation emission) where no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Allura Xper series of X-ray imaging systems due to a hazard with the foot switch pedal. The foot switch pedal may become stuck in the active position when the user releases it. If this occurs, the system may emit unintended radiation.

The recall affects approximately 5,432 Allura Xper systems that have been distributed nationwide in the United States.

The recalled product

Product
Allura Xper series
Manufacturer
Philips Medical Systems Nederland B.V.
Category
Medical Device — Diagnostic X-ray Imaging Equipment
Hazard
  • unintended-radiation
  • stuck-pedal

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)

  • Allura Xper series

Distribution

Distributed nationwide across the United States.

Related recalls

Same category