Important Safety Alerts

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