Events

Recall of SENTEC DIGITAL MONITOR SYSTEM - MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SENTEC AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32350
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Sentec ag has become aware of the fact that one of its patient monitors i.E. one sentec digital monitor (ref sdm) has been distributed although one of the device's quality tests at the end of manufacturing was failed namely the acceptance criterion for earth resistance (ground continuity test) was not met during electrical performance testing.

Device

SENTEC DIGITAL MONITOR SYSTEM - MONITOR
  • Model / Serial
    Model Catalog: SDM (Lot serial: S/N: 304829)
  • Product Description
    SENTEC DIGITAL MONITOR SYSTEM - MONITOR
  • Manufacturer
    SENTEC AG

Manufacturer

SENTEC AG
  • Manufacturer Address
    THERWIL
  • Manufacturer Parent Company (2017)
    Sentec Ag
  • Source
    HC