(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
This recall is currently active, issued January 13, 2024. It was issued by Philips North America.
- Company
- Philips North America
- Recall Initiated
- November 28, 2023
- Posted
- January 13, 2024
- Recall Number
- Z-0732-2024
- Quantity
- 254 US; 37 OUS
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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, Oman, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd.Arab.Emir., and Uzbekistan
Lot / Code Info
UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
Root Cause
Software design
Action Taken
On November 28, 2023, the firm notified affected consignees through URGENT Medical Device Correction letters. This failure is applicable to Apple iOS devices only. If customers use iOS devices (e.g. iPhone, iPad, etc.) to receive event notifications: 1) Please conduct patient monitoring at the central station or patient bedside. 2) Please do not use iOS event notifications for patient monitoring. A Philips representative will contact you to schedule a visit to install a software patch to your device which will correct the current issue. Patch PIC iX 4.2.2 will be provided for PIC iX 4.X and patch CareEvent C.03.07 will be provided for CareEvent C.03.X. If you need any further information, please contact your local Philips representative, or call 1-800-722- 9377.