Z-0820-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2014
- Initiation Date
- October 30, 2014
- Termination Date
- March 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
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
Distribution Pattern
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.
Code Information
Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031