The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.
Publicado el 12 de febrero de 2014 · Inicio del retiro: 27 de diciembre de 2013
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
Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Medical Division of Stryker Corporation
- Distribuidor
- nationwide and worldwide
- Lote
- Domestic Serial Numbers MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020 MTA7900G90007 MTA7900B90022 MTA7900B90023 MTA7900D80022 MTA7900B01006 MTA7900B01009 MTA7900B01012 MTA7900H90007 MTA7900H90008 MTA7900A01019 MTA7900A01020 MTA7900A01024 MTA7900D01028 MTA7900F01002 MTA7900H80009 MTA7900H80021 MTA7900G90016 MTA7900H90006 MTA7900K90056 MTA7900K90061 MTA7900K90063 MTA7900L90003 MTA7900L90006 MTA7900L90020 MTA7900H80057 MTA7900E01016 MTA7900I90006 MTA7900I90038 MTA7900B90020 MTA7900E80014 MTA7900E80020 MTA7900E80027 MTA7900I90023 MTA7900I90027 MTA7900E90031 MTA7900I90031 MTA7900I90041 MTA7900H90004 MTA7900B80004 MTA7900A80028 MTA7900E80054 MTA7900E01042 MTA7900D80001 MTA7900C01012 MTA7900J90018 MTA7900A01028 MTA7900E80046 MTA7900J70023 MTA7900J70024 MTA7900J70025 MTA7900J70026 MTA7900J70027 MTA7900J70031 MTA7900J70032 MTA7900E80011 MTA7900E80035 MTA7900H80014 MTA7900H80018 MTA7900H80019 MTA7900A90017 MTA7900K80010 MTA7900K80011 MTA7900K80012 MTA7900K80013 MTA7900L80001 MTA7900L80004 MTA7900L80013 MTA7900E80059 MTA7900A01014 MTA7900H90019 MTA7900H90020 MTA7900H90021 MTA7900H90022 MTA7900H90023 MTA7900D80055 MTA7900J90035 MTA7900J70028 MTA7900H80023 MTA7900A80032 MTA7900J70029 MTA7900I80029 MTA7900C80001 MTA7900C80002 MTA7900C80003 MTA7900J90027 MTA7900D80006 MTA7900E80029 MTA7900E80040 MTA7900E80065 MTA7900D01022 MTA7900E01022 MTA7900B01036 MTA7900F01010 MTA7900D90030 MTA7900K90003 MTA7900C01009 MTA7900C01025 MTA7900J60008 MTA7900A01032 MTA7900K90004 MTA7900E01029 MTA7900E90017 MTA7900J70022 MTA7900K90019 MTA7900B01040 MTA7900B01043 MTA7900B01024 MTA7900A90001 MTA7900A90005 MTA7900A90008 MTA7900E80022 MTA7900G80009 MTA7900G80011 MTA7900H80002 MTA7900H80003 MTA7900H80006 MTA7900H80007 MTA7900H80008 MTA7900H80010 MTA7900H80011 MTA7900H80012 MTA7900H80013 MTA7900L70008 MTA7900L70009 MTA7900G60063 MTA7900K40071 MTA7900B01019 MTA7900F01014 MTA7900C90010 MTA7900J80039 MTA7900K90053 MTA7900K90054 MTA7900A90012 MTA7900A90016 MTA7900A90020 MTA7900J90036 MTA7900K80005 MTA7900H80026 MTA7900L90017 MTA7900I90003 MTA7900I90008 MTA7900F01051 MTA7900I90043 MTA7900I90044 MTA7900I90046 MTA7900I90048
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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