FDA Devices Moderate Class II Terminated

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

Reported: June 20, 2018 Initiated: April 30, 2018 #Z-2143-2018

Product Description

Reason for Recall

Five warning statements are missing from the instructions for use.

Details

Recalling Firm: Philips Electronics North America Corporation
Units Affected: 4,488
Distribution: 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.
Location: Andover, MA

Frequently Asked Questions

What product was recalled? ▼

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352. Recalled by Philips Electronics North America Corporation. Units affected: 4,488.

Why was this product recalled? ▼

Five warning statements are missing from the instructions for use.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2143-2018.