GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Reported: July 30, 2014 Initiated: July 7, 2014 #Z-2114-2014
Product Description
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Reason for Recall
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 21,799 (7,635 units US, 14,164 units OUS)
- Distribution
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.. Recalled by GE Healthcare, LLC. Units affected: 21,799 (7,635 units US, 14,164 units OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2114-2014.
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