CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
FDA Recall Z-0820-2015 · Posted 2014-12-17
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Recalling FirmCarestream Health, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-10-30
Date Terminated2017-03-10
Product Quantity59 units
Reason for Recall
Reduced mammographic image quality when attempting to print true size multi-format images
Firm Action
The firm, Carestream Health Inc., sent an "URGENT: Medical Device Recall" notice dated October 28, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to use the one-up printing option rather the multi-format printing option if a hard copy is required.
Carestream has a software update that will address this issue. A Carestream service representative will contact all customers to schedule a visit to correct this software issue.
If you have any questions or concerns or would like to request the installation of the previous software version that does not have this issue, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S. please call your local service support number.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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