Philips IntelliVue Information Center iX Software Recall for Alarm Failure
Philips is recalling IntelliVue Information Center iX software because SpO2 and NBP alarms may disable without visual notification.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the disabling of critical patient safety alarms (SpO2 and NBP) without notification, which poses a significant risk of harm to patients.
Plain-English summary
Philips Medical Systems, Inc. is recalling the IntelliVue Information Center iX software (releases A.00, A.01, and A.02) due to a potential safety issue. The affected software systems are Revision A.02.05 or lower. The intended use of this software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide secondary annunciation of alarms from other networked medical devices at a centralized location. It also provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.
The recall is issued because SpO2 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification. This lack of visual notification could prevent healthcare providers from being aware of critical patient status changes.
Approximately 10,013 units are affected by this recall. The products were distributed worldwide, including the United States (nationwide) and numerous international locations such as Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Middle East. Users should contact Philips Medical Systems for further instructions on how to address this issue.
The recalled product
- Product
- Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 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, param
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 10,013
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)
- Software systems Revision A.02.05 or lower
Distribution
Distributed nationwide across the United States.
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