BEUDAMED
    FDA Recall Open, Classified

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    Recall: Z-2958-2018 · Initiated July 26, 2018

    Recall

    Recall Number
    Z-2958-2018
    Event Number
    80804
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    OLW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 26, 2018
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    Reason

    Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

    Action

    Medtronic U.S. consignees were notified via Federal Express or certified mail on July 26, 2018, and the letter informs customers to inspect their batteries. Batteries with date code 3114 or older (Week 31 of 2014) exceed 4 years of age and should be removed from the monitor and disposed of according to facilitys standard process. Included with this notification are stickers to be placed on BIS" monitors when the battery pack is removed the stickers No Battery Installed should be placed on the monitors. The BIS Vista and View monitoring systems may be used without a battery pack only if connected to AC power source with emergency power backup system (Red Outlet).

    Distribution

    Nationwide Foreign: Australia, New Zealand

    Quantity

    BIS 46,961; Spare Batteries: 6,937