BEUDAMED
    FDA Recall Terminated

    BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room.

    Recall: Z-2113-2010 · Initiated June 24, 2010

    Recall

    Recall Number
    Z-2113-2010
    Event Number
    56057
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2010
    Posted
    July 29, 2010
    Terminated
    December 3, 2010
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room.

    Reason

    Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop.

    Action

    On 06/24/2010, Spacelabs began mailing the URGENT-MEDICAL DEVICE CORRECTION letter to their US consignees and e-mailed the same letter to their foreign consignees. The letter describes the touch screen of the BleaseSirius Anesthesia machine goes blank when touched and the possibility that this failure may cause the mechanical ventilation to stop. The consignees are asked to weigh the benefits versus the risk when deciding to use the device or not until the firm upgrades the device. The letter also instructs the consignees to notify their staff about the possibility of the display failure to prevent any adverse event that may occur. The letter states that their field service engineer will contact consignees to schedule a time to visit and upgrade all affected devices at no cost. The US consignees are advised to call 1-800-522-7025, Select 2, and the foreign consignees are advised to call 1-425-657-7200 x5089 for technical support or questions regarding the recall.

    Distribution

    Worldwide Distribution -- USA, including states of IA, GA, LA, NC, TN, and TX and countries of AUSTRALIA, CHILE, CHINA, INDIA, ITALY, PHILIPPINES, MEXICO, POLAND, SINGAPORE, THAILAND, TURKEY, UNITED KINGDOM, and VENEZUELA.

    Quantity

    80 units total