Philips BRILLIANCE VOLUME CT System cooling unit may eject from gantry
A cooling unit in the Philips BRILLIANCE VOLUME computed tomography system may unexpectedly eject from the gantry, posing a risk of injury. Two affected units are being recalled.
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 involving a confirmed mechanical hazard capable of causing injury. No reported injuries or illnesses have been documented. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Philips BRILLIANCE VOLUME system is a computed tomography X-ray system intended for imaging the head and body. Model 728306 is subject to recall due to a potential mechanical failure in the cooling unit (CLU).
The cooling unit may be expelled from the CT gantry during operation. This potential expulsion may result in injury to individuals near or operating the equipment.
Two affected units have been identified with serial numbers 100100 and 100434. One unit is located in Nevada, United States, and one is located in Japan.
Operators of affected equipment should contact Philips North America LLC immediately for guidance on remediation or replacement of the cooling unit.
The recalled product
- Product
- BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
- Manufacturer
- Philips North America Llc
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 (2)
- Serial Numbers: 100100
- 100434
Distribution
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