FDAFDA · Alimentos y medicamentos·N.º oficial Z-1498-2020
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Publicado el 25 de marzo de 2020 · Inicio del retiro: 24 de febrero de 2020
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 firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- LivaNova USA Inc.
- Distribuidor
- U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none
- Lote
- Device Listing: E572259 Product Code Product Description Affected Serial Number range 16-02-80 Heater-Cooler 3T, 230V 16S10027 16S16874 16-02-81 Heater-Cooler 3T, 240V 16S10743 16S11708 16-02-82 Heater-Cooler 3T, 208V 16S10772 16S16840 16-02-83 Heater-Cooler 3T, 127V 16S11455 16S16509 16-02-85 Heater-Cooler 3T, 120V 16S10958 16S16847 16-02-95 Heater-Cooler 3T, 200V 16S12004 16S16818
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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