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Carestream Health, Inc. recalls CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis
Recalled December 24, 2014 · FDA recall Z-0820-2015 · Carestream Health
Hazard
Reduced mammographic image quality when attempting to print true size multi-format images · FDA Class II
Units
59 units
Sold at
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.
Description
Reduced mammographic image quality when attempting to print true size multi-format images
Product
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Manufacturer(s)
Carestream Health, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →