BEUDAMED
    FDA Recall Terminated

    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).

    Recall: Z-0810-2020 · Initiated December 11, 2019

    Recall

    Recall Number
    Z-0810-2020
    Event Number
    84531
    Firm
    Suntech Medical, Inc.
    FEI Number
    1036863
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 11, 2019
    Terminated
    April 10, 2023
    Address
    507 Airport Blvd, Ste 117, Morrisville, NC, 27560-8200

    Description

    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).

    Reason

    The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.

    Action

    Consignees notified via email with recall letter dated 12/11/2019. The letter identified affected product, stated reason for recall, and requested product not to be used, and to be returned to the distributor. A Recall Acknowledgement Form was requested to be returned by e-mail.

    Distribution

    No US Distribution; Internationally distributed to France, S. America

    Quantity

    384 units