Philips North America recalls (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436

Recalled January 24, 2024 · FDA recall Z-0732-2024 · Philips North America

Hazard

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. · FDA Class II

Units

254 US; 37 OUS

Sold at

Worldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN, NJ, NM, NY, OH, PA, TN, TX, WA, WV; and OUS (Foreign) distribution to countries of: Australia, Austria, Belarus, Belgium, Brazil, Canada, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, India, Indonesia, Ireland, Italy, Japan, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd.Arab.Emir., and Uzbekistan

Description

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

Product

(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436

Manufacturer(s)

Philips North America

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →