FDAFDA · Alimentos y medicamentos·N.º oficial Z-2153-2019
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
Publicado el 14 de agosto de 2019 · Inicio del retiro: 2 de mayo de 2019
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
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- SenTec AG
- Distribuidor
- Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Kuwait, Malaysia, Finland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates and United Kingdom.
- Lote
- Standard Starter Set Lots: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, and 190282. Standard Starter Set (without Service Gas) Lots:180972 and 190078
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Switzerland
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