EU Distributor/Importer Reply Form

It is important that your organization takes the actions detailed in the recall notification and confirms that you have received the recall notification. Your organization’s reply is the evidence we need to monitor the progress of this corrective action.

    9611295-9/21/21-001-C
    21 September 2021
    Eclipse Pro Holter Recorder
    Model 98700

    Distributor/Importer Details

    Company Name (required)

    Account Number

    Address (required)

    Country

    State/Province/Region

    Postal Code (required)

    Contact Name (required)

    Job Title or Function (required)

    Email (required)

    Telephone (required)

    Shipping Address (required)

    Country (required)

    State/Province/Region

    Postal Code (required)

    Submit your customer list using one of the following methods:

  • Via email at [email protected]

  • Via fax at +01 425-363-5758

    • Tick all that apply
    I confirm the receipt, the reading and understanding of the Field Safety Notice. (required for submission)
    I have checked my stock and quarantined inventory.
    I have identified customers that received or may have received this device.
    I have submitted my customer list or will provide list to Competent Authority upon request.
    I have informed the identified customers of this recall.
    I have received confirmation of reply from all identified customers.
    I have returned affected devices.

    I have destroyed affected devices.


    Neither I nor any of my customers has any affected devices in inventory.