Events

Recall of Steris Reliance EPS endoscope processor

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Steris 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
    15595
  • Event Initiated Date
    2013-10-29
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    Currently the air pipe on specific fujinon endoscopes doesn't receive forced flow during the processing cycle. a new steris flow unit 7 has been developed to facilitate forced flow of high level disinfecting solution through the air pipe and is required for reliance eps processing specific fujinon g5 and g8 type flexible gi endoscopes.
  • Action
    Instructions for use to be updated

Device

Steris Reliance EPS endoscope processor
  • Model / Serial
    Model: All models, Affected: All serial numbers
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    NZMMDSA