GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Reported: September 25, 2013 Initiated: July 20, 2011 #Z-2201-2013
Product Description
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Reason for Recall
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
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 636 (53 US, 583 OUS)
- Distribution
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.. Recalled by GE Healthcare, LLC. Units affected: 636 (53 US, 583 OUS).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2013. Severity: Moderate. Recall number: Z-2201-2013.
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