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Philips Medical Systems (Cleveland) Inc recalls Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to
Recalled January 21, 2015 · FDA recall Z-0979-2015 · Philips Medical Systems (Cleveland)
Hazard
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. · FDA Class II
Units
500 units
Sold at
US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA. The affected product was also distributed to one government consignee. The affected product was also distributed to the following foreign countries: Canada, Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Cayman Islands, China, Czech Republic, Denmark, Ecuador, Ethiopia, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Libyan Arab Jamahiriya, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, United Kingdom, and Vietnam.
Description
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Product
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →