IntelliVue

software revisions J.21.03, J.21.19

Cardiovascular Devices

2

No

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.

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.

SW Revisions: B.05.28, B.05.29, and B.05.32

Cardiovascular Devices

2

No

Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g || Product Number: 865352 || Exchange part: || 453564262491 || 453564262511 || 453564615311 || 453564615331 || 453564262571 || 453564262591 || Exchange part: || 453564262531 || 453564262551 || 453564262571 || 453564262591 || 453564615351 || 453564615371 || 453564467761 (Korea) || 453564467781 (Korea) || 453564451791 (Japan, Taiwan, Indonesia) || 453564451811 (Japan, Taiwan, Indonesia) || 453564467821 (Mexico) || 453564467841 (China) || 453564467861 (China) || Worldwide || SW Revisions: B.05.28, B.05.29, and B.05.32 || Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

Philips IntelliVue Clinical Information Portfolio Release D.XX, where XX is 00, 01, 02 or 03.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.

Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System || Software Version D.00 through D.03.

IntelliVue Patient Monitor MP2, X, MP5, MP5T, MP20, MP30, MP40 and MP50