(1) CareEvent recall
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Why was (1) CareEvent recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
- Product
- (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
- Recalling firm
- Philips North America
- Quantity
- 254 US; 37 OUS
- 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, Oman, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd.Arab.Emir., and Uzbekistan
- Recall date
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)