Events

Safety Alert for IntelliCuff Standalone

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

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
    2017-06-12
  • Event Date Posted
    2017-06-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170612.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: hamilton medical ag intellicuff standalone medical device manufacturer, hamilton medical ag, has issued a medical device safety alert concerning its intellicuff standalone. the model number involved is pn 951001 and the affected serial numbers are from 1000 to 2090. the manufacturer’s analysis of a customer complaint has identified an issue relating to the performance of the motor in the intellicuff standalone device. during use, the motor may cease to function. the alarm sounds and the red leds blink in all segments. the intellicuff standalone must be switched off to silence the alarm. the number of failures is unacceptably high causing nuisance alarms and customer complaints. according to the manufacturer’s assessment, there is no risk for the patient or user related to this failure. product recall and replacement is on-going. the manufacturer will provide the necessary hardware improvements for intellicuff standalone devices. 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 12 june 2017.

Device

IntelliCuff Standalone
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hamilton Medical AG IntelliCuff Standalone
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG