BEUDAMED
    FDA Recall Terminated

    Spacelabs 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. Anesthesia workstation for use in the hospital environment and locations not requiring portability.

    Recall: Z-0968-2013 · Initiated January 15, 2013

    Recall

    Recall Number
    Z-0968-2013
    Event Number
    64535
    Firm
    Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom
    FEI Number
    3002807992
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 15, 2013
    Posted
    March 20, 2013
    Terminated
    May 14, 2013

    Description

    Spacelabs 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. Anesthesia workstation for use in the hospital environment and locations not requiring portability.

    Reason

    A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.

    Action

    Spacelabs sent an URGENT-MEDICAL DEVICE CORRECTION letter, dated 16 January 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers until a Spacelabs representative replaces the affected product: 1) Immediately cease the use of BleaseSirius and BleaseFocus Anesthesia Workstations that shipped after 31 October 2012. 2) 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 such Service Kit. 3) Advise your staff of this situation Customers can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical support.

    Distribution

    Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.

    Quantity

    108 total (17 units in the US and 91 units outside the US)