Events

Safety Alert for Wallach LL100 Cryosurgical System

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

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
    2015-03-25
  • Event Date Posted
    2015-03-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150325.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: coopersurgical wallach ll100 cryosurgical system medical device safety alert: coopersurgical wallach ll100 cryosurgical system the manufacturer’s internal quality assurance programme has determined that one of the internal gas lines may malfunction causing the line to burst under pressure. according to the manufacturer, the potential hazard associated with the failure mode is negligible; there is no foreseen adverse event due to this failure mode. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 march 2015.

Device

Wallach LL100 Cryosurgical System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CooperSurgical Wallach LL100 Cryosurgical System
  • Manufacturer
    CooperVision

Manufacturer

CooperVision