Z-2449-2015 Class II Terminated
FDA device recall Z-2449-2015 was initiated by Carestream Health Inc on August 7, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated July 6, 2016). Affected quantity: Domestic: 76 units, Foreign: 160 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- August 7, 2015
- Termination Date
- July 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 76 units, Foreign: 160 units
Product 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 for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
Code Information
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.