Events

Safety Alert for 25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors

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

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
    2013-04-26
  • Event Date Posted
    2013-04-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426a.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: bayer healthcare 25-foot dc power cables shipped with medrad veris mr vital signs monitors medical device manufacturer, bayer healthcare, has issued a field safety notice concerning 25-foot dc power cables shipped with medrad veris mr vital signs monitors between february 2009 and february 2013 (catalogue number 3010556). according to the manufacturer, the affected power cables are being recalled due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. when the dc power supply is connected to both ac power (wall outlet) and the dc power cable, excessive heating of the dc power cable may occur. the manufacturer advises users to have visual inspection of the dc power cable against recall criteria provided by the manufacturer. the affected dc power cables confirmed by visual inspection will be replaced with new dc power cables. in the interim, users can still use the dc power cables by following instructions for safe use of dc power cable provided by manufacturer. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bayer HealthCare 25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors
  • Manufacturer
    Bayer HealthCare

Manufacturer

Bayer HealthCare
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DH