Carestream DirectView CR Software Recalled for Reduced Mammographic Image Quality
Carestream Health is recalling 59 units of DirectView CR Software due to reduced image quality when printing true size multi-format images.
What this means for you
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Carestream Health, Inc. is recalling 59 units of CARESTREAM DIRECTVIEW CR Software. The software is used to generate digital mammographic images for the screening and diagnosis of breast cancer. The recall is due to reduced mammographic image quality when attempting to print true size multi-format images.
The affected software versions are 5.7.312.27 and 5.7.312.2031. The product was distributed worldwide, including in the United States (New York, Ohio, and North Carolina) and in Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.
This is a Class II recall. The FDA has not reported any illnesses or injuries associated with this defect. Healthcare facilities should contact Carestream Health for instructions on how to resolve the issue.
The recalled product
- Product
- CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
- Manufacturer
- Carestream Health, Inc.
- Hazard
- Affected units
- 59
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 (3)
- Software Verions: 1) 5.7.312.27
- 2) 5.7.312.27
- 3) 5.7.312.2031
Distribution
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