Events

Recall of TELESENTRY RECORDER MODEL TS01

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

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
    25818
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-16
  • 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
    Aging batteries may become hot and cause burns to user due to a potential short (thermal runaway). the batteries should be replaced after 2 years or 300 charge cycles per the ifu however no manufacturing date is printed on the battery so it is difficult for the user to gauge correctly.

Device

TELESENTRY RECORDER MODEL TS01
  • Model / Serial
    Model Catalog: 101096 (Lot serial: ALL)
  • Product Description
    TELESENTRY BATTERY
  • Manufacturer
    SCOTTCARE CORPORATION

Manufacturer

SCOTTCARE CORPORATION