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Terminated

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

FDA Recall Z-2201-2013 · Posted 2013-09-16

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-07-20
Date Terminated2013-10-25
Product Quantity636 (53 US, 583 OUS)

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

Firm Action

Consignees were sent on 7/20/2011 a GE Healthcare "Important Product Information" letter. The letter was addressed to Healthcare Administrator / Risk Manager, chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Instructions, Product Correction, and Contact Information (Technical Support 1-800-558-7044).

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092027CARESCAPE MONITOR B850Ge Medical Systems Information Technologies · 2009-08-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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