The Recall Desk
HighFDA (Devices)·Z-2475-2021·Announced 2021-09-22

Philips Allura Xper Imaging System Overheating and Malfunction Recall

Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.

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 recall of a medical imaging device with no reported hospitalizations or injuries. The hazard—voltage-induced coil overheating with burning smell—represents a risk-of-harm situation, but injury has not yet been reported. This meets the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips is recalling Allura Xper series imaging systems due to a risk of early failure when hospital electrical systems provide 480 volts to the device. The high voltage can cause saturation and overheating of coils that protect the IGBTs (insulated-gate bipolar transistors) within the Auxiliary Display Units (ADUs).

When overheating occurs, a distinctive burning smell may be noticed, potentially before the ADU fails. In some cases, this burning smell may be the only warning sign.

Once the ADU fails, the system's X-ray performance degrades to Emergency Fluoroscopy mode, in which X-ray exposure is not possible and image quality is significantly reduced.

The affected systems were distributed nationwide in Idaho, Massachusetts, Michigan, Texas, and Virginia.

The recalled product

Product
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging
Hazard
  • overheating
  • device-malfunction
  • fire

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)

  • Serial number: 7

Distribution

Distributed nationwide across the United States.

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