Events

Safety Alert for Affinity® Four Birthing Bed

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

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
    2012-05-07
  • Event Date Posted
    2012-05-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120507.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: hill-rom affinity® four birthing bed medical device manufacturer, hill-rom, has issued a field safety notice concerning affinity® four birthing bed. hill-rom found that some of the affinity® four birthing beds, with serial number h331aa4785 through n081aa7966 produced prior to march 21, 2012, may experience problems with the brakes. the problem may result in unwanted bed movement. the manufacturer has developed an enhanced braking system for these beds and will modify the affected beds. the manufacturer also advised users to test the brake of the beds to make sure that it operates as normal until installation of the new braking system. according to the local supplier, solar-med limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 07 may 2012.

Device

Affinity® Four Birthing Bed
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hill-Rom Affinity® Four Birthing Bed
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom