BEUDAMED
    FDA Enforcement Class II Ongoing

    Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

    Recall: Z-1889-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1889-2020
    Event ID
    85429
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Inpeco S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    April 7, 2020
    Classification Date
    May 5, 2020
    Address
    Via San Gottardo 10, N/A, Lugano, N/A, N/A, Switzerland

    Description

    Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

    Reason

    The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

    Code Info

    Serial Numbers: AP2.0001, AP2.0002, AP2.0005, AP2.0008, AP2.0010, AP2.0011, AP2.0012, AP2.0013, AP2.0014, AP2.0016, AP2.0018, AP2.0019, AP2.0023, AP2.0024, AP2.0025, AP2.0026, AP2.0027, AP2.0032, AP2.0033, AP2.0034, AP2.0036, AP2.0039, AP2.0041, AP2.0042, AP2.0044, AP2.0045, AP2.0046, AP2.0047, AP2.0049, AP2.0050, AP2.0051, AP2.0052, AP2.0053, AP2.0054, AP2.0055, AP2.0056, AP2.0057, AP2.0058, AP2.0059, AP2.0060, AP2.0061, AP2.0062, AP2.0063, AP2.0064, AP2.0065, AP2.0067, AP2.0068, AP2.0070, AP2.0071, AP2.0072, AP2.0073, AP2.0074, AP2.0075, AP2.0076, AP2.0077, AP2.0078, AP2.0080, AP2.0081, AP2.0082, AP2.0083, AP2.0084, AP2.0085, AP2.0087, AP2.0088, AP2.0089, AP2.0090, AP2.0091, AP2.0092, AP2.0093, AP2.0094, AP2.0095, AP2.0097, AP2.0098, AP2.0099, AP2.0100, AP2.0101, AP2.0103, AP2.0105, AP2.0106, AP2.0107, AP2.0108, AP2.0109, AP2.0110, AP2.0111, AP2.0112, AP2.0113, AP2.0114, AP2.0115, AP2.0116, AP2.0117, AP2.0118, AP2.0119, AP2.0120, AP2.0121, AP2.0122, AP2.0123, AP2.0124, AP2.0125, AP2.0126, AP2.0127, AP2.0129, AP2.0130, AP2.0132, AP2.0133, AP2.0135, AP2.0136, AP2.0137, AP2.0138, AP2.0140, AP2.0141, AP2.0142, AP2.0143, AP2.0144, AP2.0145, AP2.0146, AP2.0147, AP2.0148, AP2.0149, AP2.0150, AP2.0151, AP2.0153, AP2.0154, AP2.0155, AP2.0156, AP2.0158, AP2.0159, AP2.0160, AP2.0161, AP2.0162, AP2.0163, AP2.0164, AP2.0165, AP2.0167, AP2.0170, AP2.0171, AP2.0172, AP2.0173, AP2.0174, AP2.0176, AP2.0177, AP2.0178, AP2.0179, AP2.0180, AP2.0181, AP2.0182, AP2.0183, AP2.0184, AP2.0185, AP2.0186, AP2.0187, AP2.0188, AP2.0189, AP2.0190, AP2.0191, AP2.0192, AP2.0196, AP2.0198, AP2.0199, AP2.0200, AP2.0201, AP2.0202, AP2.0203, AP2.0204, AP2.0205, AP2.0206, AP2.0207, AP2.0211, AP2.0212, AP2.0213, AP2.0215, AP2.0216, AP2.0217, AP2.0218, AP2.0219, AP2.0220, AP2.0221, AP2.0222, AP2.0223, AP2.0224, AP2.0225, AP2.0226, AP2.0227, AP2.0228, AP2.0229, AP2.0230, AP2.0231, AP2.0232, AP2.0233, AP2.0235, AP2.0236, AP2.0237, AP2.0240, AP2.0241, AP2.0242, AP2.0243, AP2.0245, AP2.0247, AP2.0248, AP2.0250, AP2.0253, AP2.0254, AP2.0255, AP2.0256, AP2.0257, AP2.0258, AP2.0259, Ap2.0260, AP2.0261, AP2.0262, AP2.0265, AP2.0266, AP2.0267, AP2.0268, AP2.0269, AP2.0270, AP2.0271, AP2.0272, AP2.0273, AP2.0276, AP2.0277, AP2.0278, AP2.0280, AP2.0281, AP2.0282, AP2.0283, AP2.0285, AP2.0286, AP2.0287, AP2.0288, AP2.0289, AP2.0290, AP2.0292, AP2.0293, AP2.0294, AP2.0295, AP2.0296, AP2.0298, AP2.0299, AP2.0300, AP2.0301, AP2.0302, AP2.0303, AP2.0304, AP2.0305, AP2.0306, AP2.0307, AP2.0308, AP2.0309, AP2.0310, AP2.0311, AP2.0313, AP2.0314, AP2.0315, AP2.0316, AP2.0318, AP2.0321, AP2.0322, AP2.0323, AP2.0324, AP2.0325, AP2.0327, AP2.0329, AP2.0330, AP2.0331, AP2.0333, AP2.0334, AP2.0336, AP2.0337, AP2.0338, AP2.0339, AP2.0340, AP2.0341, AP2.0342, AP2.0343, AP2.0345, AP2.0347, AP2.0348, AP2.0349, AP2.0350, AP2.0351, AP2.0352, AP2.0353, AP2.0354, AP2.0355, AP2.0356, AP2.0357, AP2.0358, AP2.0359, AP2.0360, AP2.0361, AP2.0362, AP2.0364, AP2.0366, AP2.0367, AP2.0368, AP2.0369, AP2.0370, AP2.0371, AP2.0372, AP2.0373, AP2.0374, AP2.0376, AP2.0377, AP2.0378, AP2.0379, APT.0009, APT.0014, APT.0058, APT.0065, APT.0093, APT.0091, APT.0136, APT.0247

    Distribution

    Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri

    Quantity

    313