CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Reported: December 24, 2014 Initiated: October 30, 2014 #Z-0820-2015
Product Description
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Reason for Recall
Reduced mammographic image quality when attempting to print true size multi-format images
Details
- Recalling Firm
- Carestream Health, Inc.
- Units Affected
- 59 units
- Distribution
- Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.. Recalled by Carestream Health, Inc.. Units affected: 59 units.
Why was this product recalled? ▼
Reduced mammographic image quality when attempting to print true size multi-format images
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0820-2015.
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