BEUDAMED
    FDA Recall Terminated

    Replacement Kit, Power PCBA with Memory PCBA. REF 14425. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.

    Recall: Z-1469-2008 · Initiated February 22, 2008

    Recall

    Recall Number
    Z-1469-2008
    Event Number
    46850
    Firm
    Cardinal Health 203, Inc
    FEI Number
    3002617992
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 22, 2008
    Posted
    August 13, 2008
    Terminated
    August 16, 2012
    Address
    17400 Medina Rd, Ste 100, Minneapolis, MN, 55447-1341

    Description

    Replacement Kit, Power PCBA with Memory PCBA. REF 14425. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.

    Reason

    The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.

    Action

    An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.

    Distribution

    Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.

    Quantity

    2,503 ( 1,128 US, 1,375 OUS)