FDA-Device2018-07-04Class II
Ingenuity Core128/Elite China 728324
Philips Medical Systems (Cleveland) Inc
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.
Sold states
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.
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
Ingenuity Core128/Elite China 728324
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2277-2018Don't want to check this manually?
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