FDA Device recall Z-2449-2015
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic…
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic… by Carestream Health, citing 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 undete….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2449-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-07 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carestream Health |
| Distribution | US |
Product
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.
Identifiers
| code_info | Software versions 5.6 and greater and 5.7 (current releases); Serial Numbers: 5029, 5569, 4067, 4754, 4131, 4100, 4096,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2023-11-15 · Carestream Health - DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid…
FDA Device · Class II · 2023-03-08 · Carestream Health - Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam…
FDA Device · Class II · 2020-01-22 · Carestream Health - OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) T…
FDA Device · Class II · 2019-05-01 · Carestream Health
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2449-2015%22
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