Reported Dec 16, 2015 · Terminated
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue…
Philips Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips IntelliVue Information Center iX (release A.00, A.01, and A.02)
- are impacted by this issue866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
- Lot codes and dates
- Software systems Revision A.02.05 or lower
- Amount recalled
- 10,013 units
Where it was sold
- Nationwide
Why it was recalled
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
This product could cause temporary or reversible health problems — stop using it.
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