FDA-Device2018-06-20Class II

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352

Philips Electronics North America Corporation
Hazard

Five warning statements are missing from the instructions for use.

Sold states
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.
Affected count
4,488
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2018

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