BEUDAMED
    FDA Recall Terminated

    Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.

    Recall: Z-1220-04 · Initiated June 4, 2004

    Recall

    Recall Number
    Z-1220-04
    Event Number
    29333
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    BZQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 4, 2004
    Posted
    July 27, 2004
    Terminated
    January 6, 2005
    Address
    1010 Murry Ridge Ln, Murrysville, PA, 15668

    Description

    Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.

    Reason

    Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.

    Action

    The recalling firm sent a recall letter to their direct accounts, which include parents and vendors regarding the problem associated with the battery packs. The recall letter advised their customers to check their inventory and if the battery pack is one of the affected recalled product to immediately contact their Customer Service Department. to arrange for replacement battery packs.

    Distribution

    The recalled product was distributed nationwide and internationally to the folllowing states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV . In regards to foreign accounts, the product was distributed to Canada and British Columbia.

    Quantity

    2726 units