FDAFDA · Alimentos y medicamentos·N.º oficial Z-2114-2014
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Publicado el 30 de julio de 2014 · Inicio del retiro: 7 de julio de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- Mfg Lot or Serial # System ID SEW10233202HA M1176021-052037 SEW10233203HA M1176021 SEW10233204HA M1176021-052037 SEW10233206HA M1176021-052037 SEW10233209HA M1176021-052037 SEW10233210HA M1176021-052037 SEW10243447HA M1176021-052037 SEW10243449HA M1176021-052037 SEW10243450HA M1176021-052037 SEW10243458HA M1176021-052037 SEW10243476HA M1176021-052037 SEW10243477HA M1176021-052037 SEW10243478HA M1176021-052037 SEW10243479HA M1176021-052037 SEW10243481HA M1176021-052037 SEW10243482HA M1176021-052037 SEW10243484HA M1176021-052037 SEW10243486HA M1176021-052037 SEW10243487HA M1176021-052037 SEW10243489HA M1176021-052037 SEW10243490HA M1176021-052037 SEW10243491HA M1176021-052037 SEW10243492HA M1176021-052037 SEW10243496HA M1176021-052037 SEW10243499HA M1176021-052037 SEW10243500HA M1176021-052037 SEW10243503HA M1176021-052037 SEW10243504HA M1176021-052037 SEW10354687HA M1176021 SEW10354688HA M1176021 SEW10354694HA M1176021-052037 SEW10354695HA M1176021-052037 SEW10354696HA M1176021-052037 SEW10354697HA M1176021-052037 SEW10354701HA M1176021-052037 SEW10354704HA M1176021 SEW10354706HA M1176021-052037 SEW10354707HA M1176021-052037 SEW10354708HA M1176021-052037 SEW10354709HA M1176021-052037 SEW10354712HA M1176021-052037 SEW10354713HA M1176021-052037 SEW10354717HA M1176021 SEW10354722HA M1176021-052037 SEW10354724HA M1176021-052037 SEW10354728HA M1176021-052037 SEW10354730HA M1176021-052037 SEW10354736HA M1176021-052037 SEW10354738HA M1176021 SEW10354740HA M1176021-052037 SEW10354741HA M1176021-052037 SEW10354746HA M1176021-052037 SEW10354749HA M1176021-052037 SEW10354751HA M1176021-052037 SEW10354752HA M1176021-052037 SEW10354754HA M1176021-052037 SEW10354756HA M1176021-052037 SEW10354757HA M1176021-052037 SEW10354758HA M1176021-052037 SEW10354759HA M1176021-052037 SEW10354760HA M1176021-052037 SEW10354761HA M1176021-052037 SEW10354762HA M1176021-052037 SEW10354763HA M1176021-052037 SEW10354764HA M1176021-052037 SEW10354767HA M1176021-052037 SEW10354768HA M1176021-052037 SEW10354773HA M1176021-052037 SEW10354774HA M1176021-052037 SEW10354775HA M1176021-052037 SEW10354776HA M1176021-052037 SEW10354777HA M1176021-052037 SEW10354778HA M1176021-052037 SEW10354780HA M1176021-052037 SEW10354781HA M1176021-052037 SEW10354783HA M1176021-052037 SEW10354784HA M1176021-052037 SEW10385221HA M1176021-052037 SEW10385223HA M1176021 SEW10385225HA M1176021 SEW10385226HA M1176021 SEW10385227HA M1176021 SEW10385228HA M1176021 SEW10385230HA M1176021-052037 SEW10385231HA M1176021-052037 SEW10385232HA M1176021-052037 SEW10385234HA M1176021-052037 SEW10385236HA M1176021 SEW10385256HA M1176021-052037 SEW10393672HA M1176021-062897 SEW10393675HA M1176021-062897 SEW10393682HA M1176021-062897 SEW10393747HA M1176021-079419 SEW10405542HA M1176021-069222 SEW10405618HA M1176021-079419 SEW10405648HA M1205643-088364 SEW10405669HA M1176021-062897 SEW10405670HA M1176021-062897 SEW10405673HA M1176021-062897 SEW10405696HA M1176021-062897 SEW10446451HA M1176021-079419 SEW10446466HA M1205643-101584 SEW10456855HA M1176021-103880 SEW10467083HA M1205643-088364 SEW10467133HA M1176021-062897 SEW10467151HA M1176021-062897 SEW10467216HA M1176021-062897 SEW10467289HA M1176021-103880 SEW10517983HA M1176021-067875 SEW10528081HA M1176021-067875 SEW10528111HA M1176021-067875 SEW11018531HA M1176021-067875 SEW11018538HA M1176021-067875 SEW11018545HA M1176021-067875 SEW11018644HA M1176021-067875 SEW11018645HA M1176021-067875 SEW11018646HA M1176021-067875 SEW11018647HA M1176021-067875 SEW11018650HA M1176021-067875 SEW11018651HA M1176021-067875 SEW11018652HA M1176021-067875 SEW11018653HA M1176021-067875 SEW11018702HA M1176021-067875 SEW11018721HA M1176021-067875 SEW11018725HA M1176021-067875 SEW11018729HA M1176021-067875 SEW11018730HA M1176021-067875 SEW11018731HA M1176021-067875 SEW11018732HA M1176021-067875 SEW11038851HA M1176021-067875 SEW11038910HA M1176021-
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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