BEUDAMED
    FDA Recall Open, Classified

    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

    Recall: Z-2405-2026 · Initiated May 12, 2026

    Recall

    Recall Number
    Z-2405-2026
    Event Number
    98963
    Firm
    Abbott Medical
    FEI Number
    2017865
    Product Code
    PNJ
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    May 12, 2026
    Posted
    June 11, 2026
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

    Reason

    Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

    Action

    On May 12 Abbott issued a Urgent Medical Device Recall notification via sales representative. Abbott ask consignees to take the following actions: Abbott has developed updated Merlin PCS 3650 programmer software (v28.9.1 rev 1 or higher) that resolves this behavior. Beginning with this notification, your Abbott Representative will upgrade programmer software to this software version . Abbott's service representative will proved a attestation to acknowledge receipt of the notification and software update. Please share this notification with others in your organization, as appropriate.

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet

    Quantity

    11182 programs