Philips Brilliance Big Bore Radiology Systems Recalled for X-Ray Tube Defect
Philips is recalling 28 Brilliance Big Bore Radiology systems due to a production defect in the X-ray tube that allows oil leakage, posing a risk to patients and users.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 28 Brilliance Big Bore Radiology 728244 systems. The recall is due to a production defect in the X-ray tube that allows oil to leak from the tube housing. If this defect re-occurs, it could pose a risk to patients or users.
The affected systems were distributed to the US states of Hawaii, Kansas, and Missouri, as well as to Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda. Specific serial numbers and UDI codes for the affected units are listed in the official recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.
The recalled product
- Product
- Brilliance Big Bore Radiology 728244
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 28
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 (6)
- UDI: (01)00884838059450(21)76064
- Serial Number: 76064
- UDI: (01)00884838059450(21)76102
- Serial Number: 76102
- UDI: (01)00884838059450(21)76094
- Serial Number: 76094
Distribution
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems (Cleveland) Inc 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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