Test

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


    [radio* Region use_label_element default:1 "European Union" "Latin America" "Other (Non-EU countries)"]
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    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.


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      Diagnostic Cardiology products include Holter, ABPM, Resting ECG, analysis and information management systems.

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