BEUDAMED
    FDA Recall Terminated

    INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian

    Recall: Z-0062-06 · Initiated August 12, 2005

    Recall

    Recall Number
    Z-0062-06
    Event Number
    33276
    Firm
    Event Medical
    FEI Number
    3006135941
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2005
    Posted
    October 15, 2005
    Terminated
    February 29, 2012
    Address
    2440 Grand Ave, Vista, CA, 92081-7829

    Description

    INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian

    Reason

    Firm received reports of combustion within the blender system of the Inspiration Ventilator.

    Action

    Customer shall be notified by an Urgent Product Safety Notfication letter dated August 12, 2005. The letter shall advise the customer with the specifics of this problem, summarise the fact that the hazard potential in negligible and will advise the customer regarding options for replacement of the Blender Module assembly (part number F710400) and the Air/O2 Filters (part number F910300). The letter will also provide the customers with a set of actions which can be completed immediately in order to ensure the integrity of their gas supplies until their unit has been upgraded.

    Distribution

    Nationwide and Canada, Europe, Japan, Latin America, Asia/Pacific, Middle East

    Quantity

    1,602 units