BEUDAMED
    FDA Recall Completed

    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    Recall: Z-2044-2023 · Initiated February 27, 2023

    Recall

    Recall Number
    Z-2044-2023
    Event Number
    92389
    Firm
    Appliedvr
    FEI Number
    3021071568
    Product Code
    QRA
    Status
    Completed
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    February 27, 2023
    Posted
    June 30, 2023
    Address
    16760 Stagg St, Ste 216, Van Nuys, CA, 91406-1642

    Description

    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    Reason

    There is the potential for the program software to malfunction which will not allow it to move forward to the next session.

    Action

    On May, 2, 2023, AppliedVR provided customers with a Medical Device Recall notification in person. The recall notification informed the customer that the device was being recalled. For questions contact AppliedVR or your Health Care Provider.

    Distribution

    US: NY OUS: None

    Quantity

    1 unit