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.
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: 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
- Affected units
- 1
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.
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.
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