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Philips Electronics North America Corporation recalls IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Recalled June 20, 2018 · FDA recall Z-2142-2018 · Philips Electronics North America
Hazard
Five warning statements are missing from the instructions for use. · FDA Class II
Units
7,178
Sold at
Worldwide Distribution -- US, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.
Description
Five warning statements are missing from the instructions for use.
Product
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →