Events

Safety Alert for CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations

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
    2013-11-28
  • Event Date Posted
    2013-11-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131128.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 healthcare cas i/ii absorbers installed in the bleasesirius and bleasefocus anesthesia workstations the united states food and drug administration (fda) has issued a medical device safety alert concerning the recall of cas i/ii absorbers installed in the bleasesirius and bleasefocus anesthesia workstations, manufactured by spacelabs healthcare. the affected products are identified as follows: part no.: 12200900, 12200901, 12200902, 12200903, 14200100 service kits part number: 050-0659-00 and 050-0901-00 manufacturing date: 21 feb 2013 through 30 sep 2013 due to a potential defect in the affected products, the bag to-vent switch in cas i/ii absorbers may fail due to loose fastening hardware in an absorber. in the worst case, this would result in a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. operation in vent mode along with all monitoring and alarm functions will continue to operate normally. customers with questions were advised to contact spacelabs healthcare for technical support. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm376772.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm376764.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 november 2013.

Device

CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Medical Device Safety Alert: Spacelabs Healthcare CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations
  • Manufacturer
    Spacelabs Healthcare

Manufacturer

Spacelabs Healthcare