BEUDAMED
    FDA Recall Terminated

    Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

    Recall: Z-2673-2020 · Initiated June 12, 2020

    Recall

    Recall Number
    Z-2673-2020
    Event Number
    85886
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    ERL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 12, 2020
    Terminated
    April 20, 2023
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

    Reason

    During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.

    Action

    On June 12th 2020 the firm send a notification to its consignees giving then the following instructions: Actions Required: 1. Immediately locate, quarantine, and return any software cards for Software 1898072 IPC Upgrade v2.7.3.0. Instructions for return are found on the Consignee Confirmation form. 2. Check the software version currently installed on your IPC Console and complete the Customer Confirmation Form. If your IPC has software v2.7.3.0 installed, do not use this console with M5 handpiece. Please record your console serial number and the software version currently loaded. 3. Return the completed Customer Confirmation Form via email to [email protected] or regular mail to: Medtronic-Xomed 6743 Southpoint Drive N Jacksonville, FL 32216 ATTN: Mike Tomberlin FCA Coordinator 4. Contact your Medtronic Field Representative to install replacement software Version 2.7.4.0 (CFN 1898073).

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA,CO, CT, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, TN, TX, UT, VA, WV, WA, WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, United Kingdom.

    Quantity

    673 units