BEUDAMED
    FDA Recall Open, Classified

    Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830

    Recall: Z-0168-2023 · Initiated October 3, 2022

    Recall

    Recall Number
    Z-0168-2023
    Event Number
    90968
    Firm
    Rebiscan, Inc.
    FEI Number
    3014522421
    Product Code
    PMW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 3, 2022
    Posted
    November 1, 2022
    Address
    100 Cambridge St, Fl 14, Boston, MA, 02114-2509

    Description

    Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830

    Reason

    Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the charge, could vent and possibly catch fire

    Action

    Rebion issued Urgent Medical Device Removal letter on 10/3/22 via Certified Mail. Letter states reason for recall, health risk and action to take: 1. Return the provided response form acknowledge receipt of this communication. 2. Stop using the device 3. Return the device, along with its power cord and carry case, to Rebion In the event that you have noticed abnormal device behavior related to charging, battery life, or excessive heat while operating the device, then please contact us immediately PLANNED ACTION TO BE TAKEN BY REBION 1. Rebion plans to evaluate and repair each device at no charge. 2. Provide each customer with a postage paid shipping label 3. Upon receipt of the device, Rebion will determine whether the battery pack is affected. 4. Affected battery packs will be replaced. 5. The device will be returned to the customer. FURTHER INFORMATION AND SUPPORT If you need further information or support for this issue, contact your Rebion representative or contact Rebion Customer Service at 877-499-9966.

    Distribution

    Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.

    Quantity

    63 units