Philips Ingenuity TF PET/CT Systems Recalled for X-Ray Tube Oil Leakage
Philips is recalling 28 Ingenuity TF PET/CT 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 28 Ingenuity TF PET/CT 882442 systems. The recall is due to a production defect in the X-Ray Tube that allows oil leakage from the tube housing. If this issue 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 available in the structured product information.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Patients and users should be aware of the potential for oil leakage from the X-Ray Tube housing.
The recalled product
- Product
- Ingenuity TF PET/CT 882442
- 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 (8)
- UDI: (01)00884838059443(21)2086
- Serial Number: 2086
- UDI: (01)00884838059443(21)2099
- Serial Number: 2099
- UDI: (01)00884838059443(21)2095
- Serial Number: 2095
- UDI: (01)00884838059443(21)2097
- Serial Number: 2097
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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