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

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.

Details from the source

Reason for recall: 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. Distribution: 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, Oma Quantity: 254 US; 37 OUS Lot/code info: UDI-DI: 00884838099128 Software: CareEvent Version C.03.X

UPC codes

00884838099128

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.