The Recall Desk
HighFDA (Devices)·Z-2276-2018·Announced 2018-07-04

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.

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 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
Category
Medical Device — Imaging 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 (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

Distributed in 3 states:

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.

See all 5 products in this recall →

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