FDA-Device2016-07-06Class II
Brilliance CT Big Bore Oncology, model #728243; 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 and cause injury to patients, operators, by standers or service personnel.
Sold states
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Affected count
3 units
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2111-2016Don't want to check this manually?
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