FDA-Device2016-07-06Class II
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Philips Medical Systems (Cleveland) Inc
Hazard
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Sold states
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Affected count
1 unit
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2016Don't want to check this manually?
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