FDA-Device2013-09-25Class II

GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.

GE Healthcare, LLC

Hazard

GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th

Sold states

Worldwide Distribution-USA (nationwide) including the states of CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF SERBIA, PORTUGAL, POLAND, PARAGUAY, NORWAY, NETHERLANDS, NEPAL, MEXICO, MALAYSIA, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BOSNIA AND HERZEGOVINA, BELGIUM, BAHRAIN, AUSTRIA, and AUSTRALIA.

Affected count

636 (53 US, 583 OUS)

Manufactured in

3000 N Grandview Blvd, N/A, Waukesha, WI, United States

Products

GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2201-2013

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