BEUDAMED
    FDA Enforcement Class I Terminated

    Quantum Pump Console

    Recall: Z-2238-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2238-2019
    Event ID
    83352
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spectrum Medical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2019
    Initiation Date
    May 29, 2019
    Classification Date
    August 23, 2019
    Termination Date
    August 21, 2020
    Address
    Harrier 4, Meteor Business Park, Cheltenham Road East, Gloucester, N/A, N/A, United Kingdom

    Description

    Quantum Pump Console

    Reason

    Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

    Code Info

    Software version 6.2.1.9; Serial Numbers PH1000005, PH1000020, PH1000027, PH1000030, PH1000077, PH1000081, PH1000082, PH1000086, PH1000087, PH1000093, PH1000100, PH1000101, PH1000102, PH1000103, PH1000109, PH1000110, PH1000112, PH1000113, PH1000114, PH1000115, PH1000120, PH1000127, PH1000129, PH1000131, PH1000132, PH1000134, PH1000135, PH1000137, PH1000139, PH1000140, PH1000141, PH1000144, PH1000145, PH1000150, PH1000156, PH1000158, PH1000159, PH1000160, PH1000161, PH1000162, PH1000165, PH1000168, PH1000170, PH1000171, PH1000172, PH1000175, PH1000176, PH1000177, PH1000178, PH1000179, PH1000180, PH1000182, PH1000201, PH1000208, PH1000209, PH1000210, PH1000211, PH1000212, PH1000213, PH1000215, PH1000233, PH1000256, PH1000257, PH1000259, PH1000438, PH1000439, PH1000440, PH1000441, PH1000442, PH1000445, PH1000455, PH1000495, PH1000498, PH1000522, PH1000615, PH1000644, PH1000645, PH1000646, PH1000647, PH1000648, PH1000649, PH1000668, PH1000669, PH1000670, PH1000682, PH1000683, PH1000684, PH1000686, PH1000687, PH1000688, PH1000689, PH1000692, PH1000722, PH1000726, PH1000727, PH1000740, PH1000742, PH1000743, PH1000744, PH1000879, PH1000880, PH1000882, PH1000885, PH1000886, PH1000895, PH1000897, PH1000939, PH1000940

    Distribution

    US distribution to NY, OH, VA, WA. International distribution to the Netherlands.

    Quantity

    108 units (8 US, 100 OUS)