Events

Safety Alert for Anesthesia Workstations and Service Kits

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

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
    2013-03-27
  • Event Date Posted
    2013-03-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130327a.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: spacelabs anesthesia workstations and service kits the u.S. food and drug administration (fda) posted a medical device safety alert concerning bleasesirius anesthesia workstation, bleasefocus anesthesia workstation, and cas i/ii absorber contained in service kits part number 12200902, 050-0659-00, and 050-0901-00, and any workstation installed with the cas i/ii absorber, manufactured by spacelabs medical. these products were manufactured and distributed from 31 oct 2012 to 15 jan 2013. there is a defect in cas i/ii absorbers in the spacelabs anesthesia workstations and service kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. until spacelabs replaces the affected product, the manufacturer advises customers to: immediately cease use of bleasesirius and bleasefocus anesthesia workstations shipped after 31 oct 2012. immediately cease use of service kits part number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a cas i/ii absorber from a service kit. for details, please refer to fda websites http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm345368.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm345346.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 march 2013.

Device

Anesthesia Workstations and Service Kits

Manufacturer

Spacelabs Medical