The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2474-2021·Announced 2021-09-22

Philips Allura Xper X-ray imaging system failures at 480V power supply

Four Philips Allura Xper X-ray imaging systems may fail prematurely when powered at 480V hospital mains, causing coil overheating and reduced imaging performance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical imaging equipment with no reported illnesses or injuries. The hazard is a documented functional defect (equipment failure at specific voltage levels) affecting imaging performance and patient care capability. It qualifies as a risk-of-harm product without reported injury, per the High severity criterion.

Plain-English summary

The Allura Xper series comprises X-ray imaging systems manufactured by Philips North America LLC used for vascular, cardiovascular, and neurovascular imaging procedures, including diagnostic, interventional, and minimally invasive applications. Four units (serial numbers 48, 66, 67, and 160) have been identified for recall, distributed across hospitals in Idaho, Massachusetts, Michigan, Texas, and Virginia.

The recalled units are subject to early-life failure when hospital mains supply 480V power. At this voltage, saturation and overheating occur in the coils that protect the IGBT components of the Arterial Detector Units (ADUs). This overheating may produce a distinctive burning smell, which may be noticed before the ADU fails completely.

When an ADU fails, the X-ray system's performance is reduced to Emergency Fluoroscopy mode only. In this mode, X-ray exposure is not possible and image quality is significantly reduced. The system becomes unable to perform the full range of diagnostic and interventional procedures for which it is designed.

Hospitals and medical facilities operating this equipment should be aware of the voltage conditions that may trigger premature failure and the potential for reduced imaging performance.

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 — Imaging Equipment / X-ray System
Hazard
Affected units
4

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 (4)

  • Serial numbers: 48
  • 66
  • 67
  • 160

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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