Philips Intellivue iX Software Recall for Patient Discharge Failure
Philips is recalling Intellivue iX Information Center Software because restarting stations in 2018 prevents patient discharge and transfer operations, causing monitoring loss.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling Intellivue iX Information Center Software, including various PIIC iX Surveillance stations and server upgrades. The recall involves 20,357 units distributed domestically and internationally.
The software contains a defect where surveillance stations restarted on or after January 1, 2018, are unable to perform patient discharge and transfer operations. Attempting these operations causes the station to restart, resulting in a short period of loss of monitoring. The source text does not report any specific injuries or illnesses associated with this defect.
Users are advised to avoid intentionally restarting their Surveillance stations in 2018 until the issue is corrected. The recall is classified as FDA Class II.
The recalled product
- Product
- Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118…
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 20,357
Distribution
Distribution scope not specified by the agency.
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