Home / Recalls / SenTec AG / Z-1134-2021

Z-1134-2021 Class II Ongoing

Recalled by SenTec AG — Therwil, N/A

Recall Details

Product Type
Devices
Report Date
February 24, 2021
Initiation Date
December 10, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 devices

Product Description

SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).

Reason for Recall

Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

Distribution Pattern

IL, PA, FL, NJ, GA, MA

Code Information

Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date

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-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-2154-2019 Class II — SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Pro (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-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)