BEUDAMED
    FDA Recall Terminated

    VNS Therapy AspireSR Generator

    Recall: Z-0462-2021 · Initiated September 28, 2020

    Recall

    Recall Number
    Z-0462-2021
    Event Number
    86570
    Firm
    LivaNova USA Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 28, 2020
    Terminated
    November 2, 2022
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy AspireSR Generator

    Reason

    Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.

    Action

    On 09/28/2020, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customers via certified 1st class return receipt informing them of an incompatibility warning message will appear with the use of the VNS Therapy Programmers with software version 11.0.4 upon interrogation of certain generators (specifically serial numbers e 1,000,000). This software incompatibility issue is due to the use of a now discontinued 7-digit serial number, thereby resulting in an error in the serial number and causing a communication disruption. For certain generators (SN e 1,000,000) using software version 11.0.4, a warning message will appear. Communication, programming, and diagnostic testing with this subset of affected Model devices will not be possible with software version 11.0.4. This software incompatibility issue does not affect the functionality of the generator itself. The device itself performs as intended when communication, programming and diagnostic testing is done with a compatible software version. Customers are instructed: For patients implanted with a device containing a 7-digit serial number (SN e 1,000,000): 1. Ensure patient has a Therapy Programmer with a software version that is compatible with affected Model 106 devices (SN e 1,000,000) in accordance with the Physicians Manual (including Model 250 version 11.0.3/11.0.5, all current software versions of Model 3000). 2. If you only have a Programmer with software version 11.0.4, contact the Recalling Firm's sales representative or Customer Quality to receive a Programmer that is compatible for all of your patients devices. Note: To check the software version of the Programmer, do the following: 1. Power on the Programmer 2. Review the software version provided on the Main Menu In addition, customer are asked to: 1. Ensure that the customer notification is communicated to all personnel with their organization who needs to be aware of this issue. 2. Fill out and Customer

    Distribution

    U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru

    Quantity

    134 generators