Z-0844-2014Class II

KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in...

Name: Z-0844-2014 KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in...
Creator: Carestream Health, Inc.
Published: 2013-12-26
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-12-26 / Terminated / root cause: software

FDA source

Carestream Health, Inc. began a recall of KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A on 2013-12-26. FDA classified it as Class II and gives the reason as "Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error". 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-0844-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-26
Posted: 2014-01-27
Terminated: 2017-03-10
Recalling firm: Eastman Kodak Company
Product: KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On December 26, 2013 Carestream Health, Inc. distributed Urgent Medical Device Recall notification letters dated December 19, 2013 to their customers via Fed Ex. Carestream Health, Inc. recommends that once the daily detector calibration process is initiated on the DR 7500 System running Version 5.X software it should not be interrupted. The calibration process should be completed only when patients are not being imaged. A Carestream Health Service representative will contact all customers to install a software modiciation to Version 5.X software which will not allow the cancellation of detector calibration. Customers will questions can call 1-800-328-2910 7 days per week on a 24 hour basis.
Quantity in commerce: 164 units Total (42 domestically & 122 internationally)
Distribution: worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.
Product codes and lots: Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0844-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0844-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27

Product code KPR

K051258Class IIKodak Directview Dr 7500 System, Model 8791345Eastman Kodak Company / cleared 2005-06-01

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)