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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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.
Related recalls
Same manufacturer · Philips Medical Systems, Inc.
See all →- ModeratePhilips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- ModeratePhilips Medical Systems Recalls Foot Switches for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- HighPhilips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- SeverePhilips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
FDA (Devices) · 2015-12-09
- SeverePhilips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
FDA (Devices) · 2015-12-09
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- HighPhilips IntelliVue Information Center Recall for Audible Alarm Loss
FDA (Devices) · 2012-12-19
- HighPhilips IntellVue Info Center Patient Monitor Recall for Reboot Loop
FDA (Devices) · 2014-06-18
- HighPhilips Intellivue iX Software Recall for Patient Discharge Failure
FDA (Devices) · 2018-03-07
- HighPhilips IntelliVue Info Center iX Software Recall for ECG Waveform Misrepresentation
FDA (Devices) · 2016-03-02
- HighPhilips IntelliVue Info Center iX Recalled for ECG Waveform Misrepresentation
FDA (Devices) · 2016-03-02
- HighPhilips IntelliVue Monitors Recalled for NBP Measurement Stoppage
FDA (Devices) · 2014-10-29