Company: Carestream Health, Inc.
Date of Enforcement Report 12/24/2014
Class lI:
PRODUCT
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Recall Number Z-0820-2015
REASON
Reduced mammographic image quality when attempting to print true size multi-format images
RECALLING FIRM/MANUFACTURER
Carestream Health, Inc., Rochester, NY on 10/30/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
Nationwide and Internationally
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