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Philips Medical Systems (Cleveland) Inc recalls Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Recalled July 6, 2016 · FDA recall Z-2111-2016 · Philips Medical Systems (Cleveland)
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. · FDA Class II
Units
3 units
Sold at
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Description
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.
Product
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →