Devices

Device Recall Philips IntelliVue Information Center iX (release A.00, A.01, and A.02)

Model / Serial
Software systems Revision A.02.05 or lower
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Philips Medical Systems, Inc.
1 Event
- Recall of Device Recall Philips IntelliVue Information Center iX (release A.00, A.01, and A.02)

Manufacturer

Philips Medical Systems, Inc.

Manufacturer Address
Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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