CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed d...
FDA Device Recall #Z-2449-2015 — Class II — August 7, 2015
Recall Summary
| Recall Number | Z-2449-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 7, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Carestream Health Inc |
| Location | Rochester, NY |
| Product Type | Devices |
| 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.
Lot / 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.
Other Recalls from Carestream Health Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2651-2017 | Class II | DRX-Revolution Mobile X-Ray System; MODEL DRXR-... | May 25, 2017 |
| Z-1138-2017 | Class II | Carestream DRX-Revolution Mobile X-Ray System, ... | Jan 12, 2017 |
| Z-1052-2017 | Class II | Carestream Touch Prime, Catalog # 1738830, and ... | Nov 21, 2016 |
| Z-2217-2016 | Class II | Carestream Touch Prime, Catalog Number 1738830,... | Jul 8, 2016 |
| Z-1594-2016 | Class II | CARESTREAM Image Suite V4; Image Suite V4: DIC... | Apr 15, 2016 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.