SenTec Membrane Changer Set (1 charger plus 1 insert) - 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.
Enforcement
- Recall Number
- Z-2155-2019
- Event ID
- 83115
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- SenTec AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2019
- Initiation Date
- May 2, 2019
- Classification Date
- August 5, 2019
- Termination Date
- December 16, 2020
- Address
- Ringstrasse 39, N/A, Therwil, N/A, N/A, Switzerland
Description
SenTec Membrane Changer Set (1 charger plus 1 insert) - 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.
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.
Lots: 180961, 181097, and 190053
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.
3 sets