FDAFDA · Food and drugs·Recall number Z-0820-2015
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Published December 24, 2014 · Recall initiated: October 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reduced mammographic image quality when attempting to print true size multi-format images
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health, Inc.
- Distributor
- 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.
- Lot
- Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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