Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2018 - (Recall #: Z-2276-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Ingenuity TF PET/CT 882442

Product Classification:

Class II

Date Initiated: March 28, 2018

Date Posted: July 4, 2018

Recall Number: Z-2276-2018

Event ID: 80176

Reason for Recall:

A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

Status: Terminated

Product Quantity: 28 total

Code Information:

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 Pattern:

The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.

Voluntary or Mandated:

Voluntary: Firm initiated