Head Holder shipped with Ingenuity Core Computed Tomography X-ray… — recall Z-2203-2015
U.S. FDA — Device Enforcement · United States · 2015-03-17 · Class II
As described by U.S. FDA — Device Enforcement: Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China,
Reported risk: A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system.
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