Events

Safety Alert for Sterrad NX Sterilizer

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
    2015-10-02
  • Event Date Posted
    2015-10-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151002a.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 sterilizer medical device manufacturer, advanced sterilization products (asp), has issued a medical device safety alert concerning its sterrad nx sterilizer [part number: 10033]. the manufacturer has recently identified that the sterrad nx sterilization system may exceed the radiated emissions international standard limit by 20 decibel micro-volt per meter (dbμv/m), which equates to 0.001 volt per meter (v/m) at a distance of 10 meters. based on the manufacturer’s analysis, the risk is low for interference to active implantable and wearable devices and other nearby electrical equipment. there is no health consequences anticipated on the issue. the manufacturer advises affected users to continue to take the precautions normally exercised for adjacency of sterrad nx sterilization system with other electromechanical equipment and electronic medical devices. the manufacturer will begin the process of correcting systems to reduce the emissions to meet the international standard limit within the next 90 days. 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 2 october 2015.

Device

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

Manufacturer

Advanced Sterilization Products