BEUDAMED
    FDA Recall Terminated

    ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC

    Recall: Z-0500-2022 · Initiated December 3, 2021

    Recall

    Recall Number
    Z-0500-2022
    Event Number
    89275
    Firm
    Konica Minolta Healthcare Americas, Inc.
    FEI Number
    2241281
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 3, 2021
    Terminated
    January 5, 2024
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC

    Reason

    lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed

    Action

    Konica Minolta issued Urgent: Medical Device Recall lmagePilot Versions 1.92 and 1.93 Letter to Dealers on 12/8/21 and Customers on 12/15/21 via Fed'X. Letter states reason for recall, health risk and action to take: To ensure the correct sampling pitch is obtained from the AeroDR or Momentum panel, please refer to the enclosed "lmagePilot & AeroDR Start-up Sequence and Notice before Shutting Down lmagePilot." Konica Minolta has issued a countermeasure to minimize the risk of a potential incident. This corrective action can only be carried out on site by a Konica Minolta trained representative. Konica Minolta Healthcare or Business Partner will contact each site to schedule a visit. A Konica Minolta Representative will be contacting you within 30 days to schedule a visit. The dispatched representative will perform a check and repair process and alert the customer if any repair was needed to any of the images on the lmagePilot server. If image repair is needed, we recommend the images that were previously sent to PACS, NAS or burned to media be exported again. Questions contact your Konica Minolta representative or the Konica Minolta 24-hour Technical Support Department at 1-800-945-0456.

    Distribution

    US Nationwide distribution.

    Quantity

    30 units