Device 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, 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.
Z-0374-2016
Product summary
- Event
- Event 70000
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,013 units
- Official record key
device-enforcement:Z-0374-2016
Official wording
Reason: Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
Code information: Software systems Revision A.02.05 or lower
Distribution pattern: Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Derived failure modes
-
Unknown
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification