BEUDAMED
    FDA Recall Open, Classified

    Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

    Recall: Z-1796-2021 · Initiated April 23, 2021

    Recall

    Recall Number
    Z-1796-2021
    Event Number
    87962
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    LNH
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 23, 2021
    Posted
    June 4, 2021
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

    Reason

    The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

    Action

    On March 23, 2021, Philips issued an Urgent Medical Device Correction notice to customers via letter stating Philips identified an issue with specified MR systems. The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities A mechanical issue was detected on these hoisting interface blocks on top of the magnet. In the initial design of the hoisting blocks, the diameter to meet the required bolt-on interface surface for the swivel eye bolts, used as lifting hardware, did not meet the required specification. HOW TO IDENTIFY AFFECTED PRODUCTS Ingenia Ambition X (781356) and Ingenia Ambition S (781359) ACTION TO BE TAKEN BY CUSTOMER / USER No action is required by the customer, as the clinical use of the MR system is not affected. In case of a planned decommissioning or movement of the magnet, and this FCO is not installed yet, please contact your local Philips representative. ACTIONS PLANNED BY PHILIPS Via FCO781 00524 a mechanical solution will be rolled out to the affected MR systems. ***Updated November 2023*** Additional customers were identified and notified on August 22, 2023.

    Distribution

    Domestic: FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Denmark, Finland, France, Germany, Iraq, Italy, Japan, Libya, Moldova, Netherlands, Oman, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.

    Quantity

    156 MR systems