Agency classClass IIOur severity:Severe FDA (Devices)·Z-1822-2017·Announced 2017-04-26

Philips Allura Xper Systems Recalled for Chiller Leak Fire Risk

Philips is recalling specific Allura Xper systems equipped with Laird chillers because a leak in the 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 constitutes a significant injury risk under the rubric for significant injury/property-damage reports or high-risk structural defects.

Plain-English summary

Philips Electronics North America Corporation is recalling specific Allura Xper and Allura CV20 systems that have a Laird chiller installed. The recall affects systems running releases 3 through 8.1, including various FD10, FD20, and CV20 models. A total of 6,992 units were distributed nationwide and worldwide, including Canada.

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

Healthcare facilities should identify if they have these specific systems with Laird chillers installed. Users should contact Philips for instructions on how to address the defect and mitigate the risk of fire or equipment damage.

The recalled product

Product: The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Systems
Hazard: fire
smoke
burn-injury
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 a 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