BEUDAMED
    FDA Recall Terminated

    Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the available storage of refrigerated Flex reagent cartridges on the Dimension system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex reagent cartridges, allowing the Dimension system to process samples without interruption.

    Recall: Z-0460-2016 · Initiated November 10, 2015

    Recall

    Recall Number
    Z-0460-2016
    Event Number
    72738
    Firm
    Siemens Healthcare Diagnostics Inc.
    FEI Number
    3002755490
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 10, 2015
    Posted
    December 22, 2015
    Terminated
    August 23, 2017
    Address
    101 Silvermine Rd, Brookfield, CT, 06804-2047

    Description

    Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the available storage of refrigerated Flex reagent cartridges on the Dimension system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex reagent cartridges, allowing the Dimension system to process samples without interruption.

    Reason

    Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.

    Action

    Siemens sent an Urgent Medical Device Correction (UMDC # DI-16-01.A.US) and Urgent Field Safety Notice (UFSN # DI-16-01.A.OUS) letters dated November 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. For questions contact your local Siemens technical support representative.

    Distribution

    US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.

    Quantity

    3