BEUDAMED
    FDA Recall Terminated

    Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with the Precess MRI Compatible Patient Monitoring System, Philips Basic Triggering Set, Philips Monitoring Sensor Set, Philips Battery Set

    Recall: Z-1307-2015 · Initiated November 20, 2014

    Recall

    Recall Number
    Z-1307-2015
    Event Number
    69812
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 20, 2014
    Posted
    March 20, 2015
    Terminated
    January 23, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with the Precess MRI Compatible Patient Monitoring System, Philips Basic Triggering Set, Philips Monitoring Sensor Set, Philips Battery Set

    Reason

    VCG battery ignited in a VCG unit when recharging.

    Action

    Consignees were informed of the recall via letter sent on November 20, 2014 via certified mailing. Field Service Engineers (FSE) will replace all affected batteries.

    Distribution

    Distributed in the following states: AL, CA, FL, GA, IL, MA, MN, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI; OUS: Australia, Austria, Belgium, China, Ecuador, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, slovenia, South Africa, Sweden, Switzerland, United Kingdom

    Quantity

    79