Carestream DRX-Evolution X-Ray System Recalled for Image Stitching Defect
Carestream Health is recalling DRX-Evolution X-ray systems due to a software defect that may cause undetected image stitching inconsistencies.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software defect that may lead to undetected image inconsistencies. No injuries or illnesses are reported, and the risk is primarily related to diagnostic accuracy rather than direct physical harm.
Plain-English summary
Carestream Health Inc is recalling the CARESTREAM DRX-EVOLUTION X-Ray System, a permanently installed diagnostic device used for general radiographic imaging. The recall affects 76 domestic units and 160 foreign units distributed worldwide, including in the United States, Australia, Canada, and other countries.
The recall is due to a software defect that impacts image alignment when using the automatic stitching option for long-length images. This defect can cause stitching inconsistencies that may go undetected on a radiograph, potentially compromising the accuracy of the diagnostic images.
The affected software versions are 5.6 and greater, and 5.7. Users should contact Carestream Health for further instructions on resolving the software defect.
The recalled product
- 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.
- Manufacturer
- Carestream Health Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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