Events

Safety Alert for STERRAD NX System

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

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
    2017-01-10
  • Event Date Posted
    2017-01-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170110b.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: advanced sterilization products sterrad nx system medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its sterrad nx system [part number: 10033, 10033-022]. the manufacturer has identified that in a rare sequence of events following an external power outage, the system door interlock can become disengaged during system reboot for a 20-second duration. the manufacturer is sending this medical device safety alert to remind customers to follow the instructions in the sterrad nx system user’s guide. specifically, after cycle initiation, the user should only open the chamber door of the sterrad nx system when prompted by the graphical user interface (gui) per the user’s guide. the manufacturer advises users to follow the instructions in the user’s guide, chapter 5 for normal operation. specifically, after cycle initiation, the user should only open the chamber door of the sterrad nx system when prompted by the gui per the user’s guide. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 january 2017.

Device

STERRAD NX System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD NX System
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products