Philips Ingenuity Core128 MRI Systems Recalled for X-Ray Tube Oil Leakage
Philips is recalling 28 Ingenuity Core128 MRI systems because a production defect in the X-Ray Tube 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 is classified as FDA Class II, and the source text explicitly states the defect 'could pose a risk for patients or users' without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 28 Ingenuity Core128 728323 MRI 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 to arrange for inspection and repair of the affected X-Ray Tubes. Patients and users should be aware of the potential for oil leakage and follow the instructions provided by their healthcare provider or the manufacturer.
The recalled product
- Product
- Ingenuity Core128 728323
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — MRI System
- 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 (15)
- UDI: (01)00884838059504(21)320403
- Serial Number: 320403
- UDI: (01)00884838059504(21)320405
- Serial Number: 320405
- UDI: (01)00884838059504(21)320406
- Serial Number: 320406
- UDI: (01)00884838059504(21)336321
- Serial Number: 336321
- UDI: (01)00884838059504(21)320411
- Serial Number: 320411
- UDI: (01)00884838059504(21)336323
- Serial Number: 336323
- UDI: (01)00884838059504(21)320425
- Serial Number: 320425
- Serial Number: 320122
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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