Events

Safety Alert for ABP Monitor, Model 90217A

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Spacelabs 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
    2011-11-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115a.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
    Mhra fsn safety alert: spacelabs healthcare abp monitor, model 90217a the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on ambulatory blood pressure monitor, model 90217a, manufactured by spacelabs healthcare. the manufacturer has identified a potential error code associated with the use of the product. if external pressure is applied to the cuff during deflation, the monitor will cease to function and display an ec75 error code. according to the manufacturer, there have been no injuries associated with this issue. spacelabs healthcare suggests the users to cycle the power off if error code is observed. the manufacturer is in the progress of upgrading the software. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

ABP Monitor, Model 90217A
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Spacelabs Healthcare ABP Monitor, Model 90217A
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare