FDA-Device2024-01-24Class II
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
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.
Sold states
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
Affected count
254 US; 37 OUS
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0732-2024Don't want to check this manually?
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