Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Publicado el 18 de noviembre de 2020 · Inicio del retiro: 12 de septiembre de 2020
Estado reportado al momento de publicación: Completed — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Fresenius Medical Care Holdings, Inc.
- Distribuidor
- Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.
- Lote
- All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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