medical Class II Updated 2018-07-04

Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/CT 882442

Recalled Product

Ingenuity TF PET/CT 882442


Hazard / Issue

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.

Issued by

FDA

Affected States: HI, KS, MO
Lot/Code Info: 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
View official government recall

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