Philips Electronics North America Corporation recalls IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350

Recall date

April 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2141-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

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;…

Why it was recalled

Five warning statements are missing from the instructions for use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350