Philips Patient Information Center iX Network Connectivity Issue Affects Settings Synchronization
Philips Patient Information Center iX devices may fail to synchronize settings when network DHCP leases expire during offline operation, causing the devices to receive new IP addresses that are not recognized after reconnection.
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 is an FDA Class II recall with no reported injuries or illnesses. The hazard is a theoretical risk from potential failure in settings synchronization in a patient monitoring device rather than an actual reported patient harm. Per the rubric, when the source explicitly states no illnesses/injuries and the hazard is theoretical, the score is at most 3.
Plain-English summary
Philips Patient Information Center iX and Patient Information Center iX Expand (Software Revision 4.0.1) are networked medical devices used for patient monitoring in healthcare settings. The recalled devices (591 units) contain a software issue where the Dynamic Host Configuration Protocol (DHCP) lease can expire during extended offline operation.
When a device reconnects to the network after the DHCP lease expires, it receives a new IP address. The Patient Information Center iX software does not recognize the new IP address, which causes the expected settings synchronization between the devices to fail.
This affects all Patient Information Center iX units (Product Code 866386) and Patient Information Center iX Expand units (Product Code 866390) running Software Revision 4.0.1 that have been distributed worldwide, including throughout the United States. A complete list of affected serial numbers is provided in the FDA recall notice.
Users should contact Philips North America for guidance on software updates or corrective actions. No injuries or illnesses have been reported associated with this issue.
The recalled product
- Product
- Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
- Manufacturer
- Philips North America
- Affected units
- 591
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: 00884838104594
Distribution
Distributed nationwide across the United States.
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