Philips Ingenuity Core X-Ray Tube Recall for Oil Leakage Risk
Philips is recalling 28 Ingenuity Core systems due to a production defect in the X-Ray Tube that allows oil leakage, posing a risk to patients or users.
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: 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 Philips Ingenuity Core 728321 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 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. 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. Consumers and patients should consult their healthcare provider for guidance regarding the use of these systems.
The recalled product
- Product
- Philips Ingenuity Core 728321
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — X-Ray Equipment
- 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 (10)
- UDI: (01)00884838059498(21)333169
- Serial Number: 333169
- UDI: (01)00884838059498(21)310377
- Serial Number: 310377
- UDI: (01)00884838059498(21)310375
- Serial Number: 310375
- UDI: (01)00884838059498(21)333171
- Serial Number: 333171
- UDI: (01)00884838059498(21)333172
- Serial Number: 333172
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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