The Recall Desk
HighFDA (Devices)·Z-0724-2022·Announced 2022-03-16

Philips Allura Xper X-ray systems cooling system leak poses fire risk

Philips Allura Xper interventional X-ray systems may experience cooling liquid leaks that could drip on electrical components, creating risk of fire, smoke, or burning odors. No injuries have been reported.

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 involving a potential risk of fire, smoke, and electrical damage if cooling liquid contacts electrical components. No injuries, illnesses, or deaths have been reported. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Philips North America has recalled specific Allura Xper interventional fluoroscopic X-ray systems with Laird chillers that lack extended drip trays. A leak in the detector cooling system allows cooling liquid to escape outside the drip tray and potentially drip onto electrical components in the R cabinet located in the technical room.

Cooling liquid contacting electrical components could damage the system and potentially cause thermal events such as burning odors, smoke, or fire.

In the United States, 63 systems are affected. Worldwide, 127 additional systems are affected across countries including Argentina, Austria, Bangladesh, Brazil, Chile, China, Denmark, Dominican Republic, France, Germany, Greece, India, Indonesia, Iran, Israel, Italy, Japan, South Korea, Malaysia, Mexico, the Netherlands, the Philippines, Russia, Saudi Arabia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, the United Kingdom, and the US Virgin Islands.

No injuries or illnesses have been reported to date. Affected model numbers and specific serial numbers are identified in the FDA recall notice.

The recalled product

Product
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023
Manufacturer
Philips North America Llc
Category
Medical Device — Fluoroscopic X-ray System
Hazard
  • fire
  • smoke
  • electrical-damage

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 (2)

  • 82
  • 94 US UDI: (01)00884838054219(21)94 OUS: S/N:6

Distribution

Distributed nationwide across the United States.

Related recalls

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