CareEvent Medical Device Push Notifications May Fail to Send
The CareEvent patient monitoring device may fail to send push notifications, potentially delaying detection of patient condition changes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The issue represents a risk-of-harm scenario where device notification failures could delay patient care, but the hazard is theoretical without reported adverse events.
Plain-English summary
The CareEvent patient monitoring devices (Model Nos. 866435 and 866436) manufactured by Philips North America have been recalled. These devices are designed to send push notifications to monitor patient conditions.
Under certain conditions, the push notifications may fail to send. When notifications fail, it could delay the detection of changes in a patient's condition and potentially result in patient harm. No illnesses or injuries have been reported related to this issue.
Approximately 254 devices have been distributed in the United States, and 37 devices have been distributed internationally. The affected devices use CareEvent Version C.03.X software (UDI-DI: 00884838099128).
The recalled product
- Product
- (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
- Manufacturer
- Philips North America
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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