FDAFDA · Food and drugs·Recall number Z-0732-2024
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Published January 24, 2024 · Recall initiated: November 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- 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
- Lot
- UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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