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Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
Recalled July 6, 2016 · FDA recall Z-2114-2016 · 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 causing injury to patients, operators, by-standers and service personnel. · FDA Class II
Units
14 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 causing injury to patients, operators, by-standers and service personnel.
Product
Ingenuity Core 128, model #728323; 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 →