Ingenuity Core 128, model #728323; Intended to produce cross… — recall Z-2114-2016
U.S. FDA — Device Enforcement · United States · 2016-06-21 · Class II
As described by U.S. FDA — Device Enforcement: Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Reported risk: 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.
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