Events

Safety Alert for Sigma Delta Vaporizer

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

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
    2013-04-09
  • Event Date Posted
    2013-04-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130409b.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: penlon sigma delta vaporizer medical device manufacturer, penlon ltd. issued a medical device safety alert concerning penlon sigma delta vaporizer. it has come to the manufacturer’s attention of an instance where the installation and pre-use checks listed in the user manual may not have been followed prior the clinical use of the vaporizer. penlon ltd. has updated the installation and daily pre-use check sections of the user manual to ensure that the instructions are explicit and clear. the manufacturer reminds and requests users to follow the instructions for daily pre-use checks and initial checks and servicing. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

Sigma Delta Vaporizer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Penlon Sigma Delta Vaporizer
  • Manufacturer
    Penlon Ltd

Manufacturer

Penlon Ltd