Recall Z-0732-2024— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2023-11-28. It names 2 FDA 510(k) clearances: K161164, K153702. Product: (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436. 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..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-28
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K161164 — CareEvent inclusive of the CareEvent Mobile Application accessory
- K153702 — M3290B Philips IntelliVue Information Center iX
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.