BEUDAMED
    FDA Recall Terminated

    Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS

    Recall: Z-1408-06 · Initiated June 22, 2006

    Recall

    Recall Number
    Z-1408-06
    Event Number
    35737
    Firm
    Steris Corporation
    FEI Number
    1043572
    Product Code
    FLG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2006
    Posted
    August 25, 2006
    Terminated
    January 8, 2007
    Address
    2720 Gunter Park Dr E, Montgomery, AL, 36109-1410

    Description

    Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS

    Reason

    Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.

    Action

    The firm sent out a certified letter to all affected consignees alerting them to problems with the device on 6/22/06.

    Distribution

    Worldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia.

    Quantity

    353 units