Agency classClass IIOur severity:Severe FDA (Devices)·Z-1820-2017·Announced 2017-04-26

Philips Recalls Allura Xper Systems Due to Chiller Leak Fire Risk

Philips is recalling specific Allura Xper medical imaging systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential fire hazard (smoke or fire) in a medical device, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk structural defects, warranting a Severe classification.

Plain-English summary

Philips Electronics North America Corporation is recalling specific models of the Allura Xper medical imaging system, including the FD10, FD10/10, FD20/10, and FD20/20 variants, as well as the Allura Xper Release 8.2. The recall affects 6,992 devices distributed nationwide and worldwide, including Canada. The affected units are identified by the presence of a Laird Chiller installed in the system.

The recall is being issued due to a defect in the detector cooling system where cooling liquid may leak outside the drip tray of the chiller. If this occurs, the liquid may drip onto electrical components located in the R cabinet in the technical room. This contact could lead to system damage and potentially cause thermal events, such as a burning odor, smoke, or fire.

Healthcare facilities and consumers with these specific devices should contact Philips for instructions on how to address the defect. The source text does not specify a deadline or additional remediation steps beyond the recall notice.

The recalled product

Product: Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Equipment
Hazard: fire
smoke
liquid-leak
Affected units: 6,992

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)

Devices with Laird Chiller.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Philips Electronics North America Corporation 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 →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · fire