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Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128 728323
Recalled December 14, 2016 · FDA recall Z-0696-2017 · Philips Medical Systems (Cleveland)
Hazard
Software error due to the filament on timer · FDA Class II
Units
509
Sold at
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
Description
Software error due to the filament on timer
Product
Ingenuity Core 128 728323
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →