Events

Safety Alert for Modulith SLX-F2

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

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
    2016-03-01
  • Event Date Posted
    2016-03-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160301.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: storz medical modulith slx-f2 the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning modulith slx-f2 manufactured by storz medical. the affected serial numbers are 0r.079, 0r.269, 0r.110 and 0r.299. the system includes a table insert from carbon fibre as part of the optional urology kit. the manufacturer has observed that due to the addition of tolerances of the table insert and the table cutout, the table insert can slip out of place. during patient treatment the slipping of the insert plate can lead to a sudden downward movement of the patient. according to the manufacturer, this patient movement will be compensated by the patient foil after a few centimeters. nevertheless, if at this moment an endoscopic instrument is inserted into the patient, serious injury may occur. to prevent the risk of injuries, the manufacturer advises that user must make sure that the lithotripter is no longer operated in combination with the actual carbon fibre insert plate. for details, please refer to the mhra website:https://www.Gov.Uk/drug-device-alerts/field-safety-notices-22-february-to-26-february-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 march 2016.

Device

Modulith SLX-F2
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Storz Medical Modulith SLX-F2
  • Manufacturer
    Storz Medical

Manufacturer

Storz Medical