Agency classClass IIOur severity:High FDA (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.

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 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…
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.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · fire