Devices

Philips IntelliVue Monitors

Model / Serial
software revisions J.21.03, J.21.19
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.
Product Description
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. || Model Product || MP5 M8105A; || MP5SC M8105AS; || MP5T M8105AT; || MP5 Upgrade M8105AU ; || MP5SC Upgrade 866327 || The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
Manufacturer
Philips Medical Systems, Inc.
1 Event
- Recall of Philips IntelliVue Monitors

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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