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Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/CT 882442
Recalled July 4, 2018 · FDA recall Z-2276-2018 · Philips Medical Systems (Cleveland)
Hazard
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. · FDA Class II
Units
28 total
Sold at
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.
Description
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.
Product
Ingenuity TF PET/CT 882442
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →