(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
FDA device recall Z-0732-2024 · posted 2024-01-13 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- 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.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 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,
- Date initiated
- 2023-11-28
- Date posted
- 2024-01-13
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CareEvent inclusive of the CareEvent Mobile Application accessory (K161164) | Philips Medical Systems | 2016-06-24 |
| M3290B Philips IntelliVue Information Center iX (K153702) | Philips Medical Systems | 2016-06-13 |