GE Healthcare, LLC recalls GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahos

Recalled July 30, 2014 · FDA recall Z-2114-2014 · GE Healthcare

Hazard

Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor. · FDA Class II

Units

21,799 (7,635 units US, 14,164 units OUS)

Sold at

Worldwide distribution. US nationwide including Puerto Rico, ZAMBIA, YEMEN, VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, UNITED REPUBLIC OF TANZANIA, TAJIKISTAN, TAIWAN, SYRIA, SWITZERLAND, SWEDEN, SRILANKA, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¿D¿RATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLAND, NAMIBIA, MYANMAR, MOROCCO, MEXICO, MAURITIUS, MALAYSIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JORDAN, Italy, JAPAN, JAMAICA, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GREECE, GERMANY, GEORGIA, FRANCE, FINLAND, ESTONIA, EL SALVADOR, Egypt, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRUNEI, BRAZIL, BOLIVIA, BERMUDA, BELGIUM, BANGLADESH, BAHRAIN, BAHAMAS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA.

Description

Product

GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →