Recall Z-0732-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
| Date | Jan 13, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 an |
| 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, |
| FDA record | Open on fda.gov |