The Recall Desk
HighFDA (Devices)·Z-0725-2022·Announced 2022-03-16

Philips X-ray System Cooling Leak Poses Fire Risk

Philips Allura CV20 X-ray systems with certain Laird chillers may leak cooling liquid onto electrical components, potentially causing fire or smoke. Affected systems should not be operated until the issue is addressed.

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: FDA Class II medical device recall. The potential hazard—fire, smoke, or electrical damage—is serious, but no injuries or deaths have been reported. The hazard is theoretical rather than a realized incident. Per the rubric, risk-of-harm products without reported injury receive a High severity score (3).

Plain-English summary

Philips North America LLC is recalling Philips Allura CV20 Interventional Fluoroscopic X-ray System units equipped with a Laird chiller lacking an extended drip tray (Model 722031). A leak in the detector cooling system is the basis for this recall.

The cooling liquid may leak outside the chiller's drip tray and flow onto electrical components in the R cabinet located in the system's technical room. This could damage the system and potentially cause thermal events such as burning odor, smoke, or fire.

These systems have been distributed across the United States and internationally. Facility staff and engineers with affected equipment should contact Philips for remediation instructions and should not operate the system until the cooling system issue is resolved.

The recalled product

Product
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • cooling-liquid-leak
  • 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 (1)

  • S/N: OUS 109

Distribution

Distributed nationwide across the United States.

Related recalls

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