Events

Safety Alert for Sonopet Console

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Stryker.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-06-10
  • Event Date Posted
    2013-06-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130610.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: stryker sonopet console the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning sonopet console, manufactured by stryker. the affected catalogue number is 5450852000 and the affected serial numbers are 1134000114, 1134000124, 1134000134, 1134000144, 1134000184, 1134000204 & 1209400174. according to the tga, the manufacturer has received reports that the irrigation pump may not function and audible alarm may not sound. in case where the irrigation pump fails, saline would not be provided to the tip. the manufacturer will be replacing affected units with a loan unit until the unit is repaired. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00578-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 jun 2013.

Device

Sonopet Console
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Stryker Sonopet Console
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH