Events

Recall of Ellipse VR CD1277-36Q

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by St Jude Medical (USA).

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
    22821
  • Event Initiated Date
    2018-05-28
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Reason
    As part of a planned series of updates that began in 2017 with the release of merlin@home v8.2.2 software in april 2017, and continued with updates announced in august 2017 (cybersecurity update for low voltage devices), the manufacturer is planning to proceed with further firmware and software updates for certain icds/crt-ds (high voltage) intended to:, 1. improve cybersecurity protection., 2. incorporate the battery performance alert (bpa) for device-based detection of abnormal battery performance.
  • Action
    Software to be upgraded

Device

Ellipse VR CD1277-36Q

Manufacturer

St Jude Medical (USA)
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA