Philips Patient Information Center iX: Push Notifications May Fail to Send
Philips Patient Information Center iX devices may fail to send push notifications under certain conditions, potentially delaying detection of patient condition changes. A total of 814 units have been recalled worldwide.
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: This recall involves a patient monitoring device with a functional failure that could delay detection of patient condition changes. The device failure presents a concrete risk of patient harm through delayed clinical response, yet no illnesses or injuries have been reported. This fits the criterion of a risk-of-harm medical device without reported injury.
Plain-English summary
Philips North America has recalled three models of the Patient Information Center iX system (Model Nos. 866389, 866390, and 866424). These are medical devices used in healthcare settings to display patient information and alert clinicians to changes in patient status.
The devices may fail to send push notifications to users under certain conditions. Push notifications alert clinicians to important changes in patient condition. When notifications fail, detection of patient condition changes may be delayed, potentially affecting clinical decision-making and patient care.
The recall affects 41 units in the United States and 773 units distributed to healthcare facilities in 33 countries worldwide. Healthcare providers using these devices should contact Philips North America for information about addressing this issue.
The recalled product
- Product
- (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
- Manufacturer
- Philips North America
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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