Home / Recalls / SenTec AG / Z-2154-2019

Z-2154-2019 Class II Terminated

Recalled by SenTec AG — Therwil, N/A

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
May 2, 2019
Termination Date
December 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 pcs

Product Description

SenTec Neonatal Starter Set with and without Service Gas (2 Chargers 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.

Reason for Recall

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.

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.

Code Information

Neonatal Starter Set Lots: 181089, 190051 and 190242. Neonatal Starter Set (without Service Gas) Lots: 181068 and 190242

Other recalls by SenTec AG

  • Z-2592-2023 Class II — Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane (July 25, 2023)
  • Z-1980-2023 Class II — V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System ( (May 2, 2023)
  • Z-0148-2023 Class II — sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ski (August 22, 2022)
  • Z-1134-2021 Class II — SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor ind (December 10, 2020)
  • Z-2155-2019 Class II — SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indica (May 2, 2019)
  • Z-2153-2019 Class II — SenTec Standard Starter Set with and without Service Gas (2 changers each) - Pro (May 2, 2019)
  • Z-2152-2019 Class II — SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for c (May 2, 2019)
  • Z-2156-2019 Class II — SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuo (May 2, 2019)
  • Z-0088-2017 Class II — SDMS (SenTec Digital Monitoring System) (September 15, 2016)
  • Z-1501-2015 Class II — Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenT (March 25, 2015)