Important Safety Alerts

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/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