Events

Recall of Steris Caviwave Pro Ultrasonic Cleaning System

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
    18346
  • Event Initiated Date
    2015-04-10
  • 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
    Steris has learned through customer feedback and field service experience that should the caviwave pro ultrasonic cleaning system experience a temporary interruption in electrical power during a processing cycle, it is possible that the circulation pump or ultrasonic generator may stop functioning. the machine does not provide an alert notifying the user of this device malfunction.
  • Action
    Product to be modified

Device

Steris Caviwave Pro Ultrasonic Cleaning System
  • Model / Serial
    Model: Product Codes: ST-CRP1172, ST-CRP1172401, Affected: All serial numbers
  • Manufacturer
    Steris Corporation

Manufacturer

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