Home / Recalls / Sentec AG / Z-2199-2012

Z-2199-2012 Class II Terminated

Recalled by Sentec AG — Therwil, Baselland

Recall Details

Product Type
Devices
Report Date
August 22, 2012
Initiation Date
July 9, 2012
Termination Date
October 11, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8

Product Description

SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

Reason for Recall

SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Distribution Pattern

Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.

Code Information

310701 311100 311239 310996 311920 311943 311958 312132

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-2156-2019 Class II — SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuo (May 2, 2019)
  • 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-2154-2019 Class II — SenTec Neonatal Starter Set with and without Service Gas (2 Chargers 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-0088-2017 Class II — SDMS (SenTec Digital Monitoring System) (September 15, 2016)