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Philips Medical Systems (Cleveland) Inc recalls Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Recalled July 29, 2015 · FDA recall Z-2205-2015 · Philips Medical Systems (Cleveland)
Hazard
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system. · FDA Class II
Units
66 units
Sold at
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, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.
Description
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
Product
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →