Philips Ingenuity Core128/Elite X-Ray Tube Recall for Oil Leakage
Philips is recalling specific Ingenuity Core128/Elite X-ray tubes due to a production defect 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 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 High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling specific units of the Ingenuity Core128/Elite China 728324 X-ray tube. The recall is due to a detected production defect in the X-ray tube that allows oil to leak from the tube housing. If this leakage were to re-occur, 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. The recall covers eight specific serial numbers: 336856, 336851, 336849, 336852, 336853, 336855, 336854, and 336850.
Healthcare facilities and users should identify if they possess any of the affected serial numbers and contact Philips Medical Systems for further instructions on the recall.
The recalled product
- Product
- Ingenuity Core128/Elite China 728324
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — X-Ray Equipment
- Hazard
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 (16)
- UDI: (01)00884838059863(21)336856
- Serial Number: 336856
- UDI: (01)00884838059863(21)336851
- Serial Number: 336851
- UDI: (01)00884838059863(21)336849
- Serial Number: 336849
- UDI: (01)00884838059863(21)336852
- Serial Number: 336852
- UDI: (01)00884838059863(21)336853
- Serial Number: 336853
- UDI: (01)00884838059863(21)336855
- Serial Number: 336855
- UDI: (01)00884838059863(21)336854
- Serial Number: 336854
- UDI: (01)00884838059863(21)336850
- Serial Number: 336850
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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