Events

Recall of H3+ (PLUS) HOLTER RECORDER

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

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
    134842
  • Event Risk Class
    III
  • Event Initiated Date
    2015-11-06
  • 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
    An issue with the placement of a capacitor in the h3+ digital holter 48 hour recorders has resulted in reduced battery life causing the recorder to record for less than the expected time. h3+ digital holter recorders with serial numbers between 115110248400 and 115410276012 fail to meet the claim of 24-48 hours recording time.

Device

H3+ (PLUS) HOLTER RECORDER
  • Model / Serial
    Model Catalog: BURH3PR (Lot serial: > 10 numbers contact mfg.); Model Catalog: H3PLUS-BAD-XXXXX (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    H3+ (PLUS) HOLTER RECORDER
  • Manufacturer
    MORTARA INSTRUMENT INC.

Manufacturer

MORTARA INSTRUMENT INC.