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Recall Observatory FDA recall evidence

Device product

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.

Z-2153-2019

May 02, 2019

Class II

Product summary

Firm
SenTec AG
Event
Event 83115
Status
Terminated
Classification
Class II
Quantity
22 pcs
Official record key
device-enforcement:Z-2153-2019

Official wording

Reason: 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.

Code information: Standard Starter Set Lots: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, and 190282. Standard Starter Set (without Service Gas) Lots:180972 and 190078

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.