The Recall Desk
SevereFDA (Devices)·Z-1821-2017·Announced 2017-04-26

Philips UNIQ X-ray Systems Recalled for Potential Fire Hazard

Philips is recalling UNIQ X-ray systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

What this means for you

Illness, injury, or structural failure has been reported. 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) which constitutes a risk of significant injury or property damage, aligning with the 'Severe' criteria for risk-of-harm products.

Plain-English summary

Philips Electronics North America Corporation is recalling specific UNIQ X-ray systems, including the UNIQ FD10, FD10/10, FD20/10, and FD20/20 models, as well as their associated OR Tables. The recall involves 6,992 devices distributed nationwide and worldwide, including Canada. The affected units are identified by the presence of a Laird Chiller.

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 and users of these devices should contact Philips for instructions on how to address the defect. The source text does not specify a particular action for consumers to take immediately, but the hazard involves potential fire and smoke.

The recalled product

Product
UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — X-ray Systems
Hazard
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 →

Related recalls

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · fire

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