115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Publicado el 11 de junio de 2014 · Inicio del retiro: 8 de enero 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
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Cincinnati Sub-Zero Products Inc
- Distribuidor
- The product was distributed to one customer in MI, and internationally (Taiwan)
- Lote
- Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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