Z-0820-2015Class II

CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and...

Name: Z-0820-2015 CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and...
Creator: Carestream Health, Inc.
Published: 2014-10-30
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2014-10-30 / Terminated / root cause: software

FDA source

Carestream Health, Inc. began a recall of CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer on 2014-10-30. FDA classified it as Class II and gives the reason as "Reduced mammographic image quality when attempting to print true size multi-format images". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0820-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-30
Posted: 2014-12-17
Terminated: 2017-03-10
Recalling firm: Eastman Kodak Company
Product: CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Reduced mammographic image quality when attempting to print true size multi-format images
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 59 units
Distribution: 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.
Product codes and lots: Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0820-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0820-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)