BEUDAMED
    FDA Enforcement Class II Terminated

    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

    Recall: Z-2449-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2449-2015
    Event ID
    71848
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    August 7, 2015
    Classification Date
    August 21, 2015
    Termination Date
    July 6, 2016
    Address
    150 Verona St, N/A, Rochester, NY, 14608-1733, United States

    Description

    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

    Reason

    Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

    Code Info

    Software versions 5.6 and greater and 5.7 (current releases); Serial Numbers: 5029, 5569, 4067, 4754, 4131, 4100, 4096, 4076, 4569, 4570, 4588, 4670, 4767, 4879, 5266, 5393, 5408, 5442, 5572, 5573, 5555, 5556, 5563, 4146, 4679, 4702, 4703, 4704, 4801, 5090, 5154, 4787, 4069, 4074, 4344, 4085, 4058, 4084, 5470, 5158, 4086, 4099, 4073, 4665, 5241, 5303, 5304, 4639, 5350, 5352, 5429, 5508, 4696, 4763, 5182, 4291, 5037, 5554, 4192, 4117, 4172, 4207, 4225, 4239, 4278, 4301, 4310, 4328, 4333, 4338, 4366, 4384, 4421, 4427, 4442, 4443, 4447, 4465, 4499, 4523, 4534, 4538, 4539, 4692, 4822, 4861, 4875, 5128, 5131, 5174, 5553, 5579, 5580, 5597, 5628, 4320, 5309, 5042, 4807, 4808, 4809, 4810, 5493, 4266, 4711, 5327, 4125, 4143, 4097, 4156, 4282, 4287, 4289, 4258, 4742, 4964, 4784, 5050, 5551, 4233, 4644, 4082, 4113, 4196, 4683, 4309, 4315, 4064, 4256, 4987, 4624, 4585, 4882, 5362, 4004, 5377, 5418, 4300, 4308, 4627, 4638, 5138, 5251, 5360, 4947, 5620, 4985, 5403, 5495, 5560, 5544, 5545, 5621, 5622, 5451, 5282, 5645, 4724, 4298, 4269, 4756, 4418, 5273, 5178, 5179, 5443, 5197, 5389, 5584, 5473, 4899, 5334, 5431, 4990 --- NOTE: Additional serial numbers at foreign consignees to be determined upon reporting part usage.

    Distribution

    Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.

    Quantity

    Domestic: 76 units, Foreign: 160 units