Z-0797-2014Class II

DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4...

Name: Z-0797-2014 DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4...
Creator: Carestream Health, Inc.
Published: 2013-11-25
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-11-25 / Terminated / root cause: manufacturing process

FDA source

Carestream Health, Inc. began a recall of DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube... on 2013-11-25. FDA classified it as Class II and gives the reason as "Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0797-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2014-01-21
Terminated: 2016-06-30
Recalling firm: Eastman Kodak Company
Product: DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Carestream Health Inc, sent an "URGENT: Medical Device Recall" notice dated November 20, 2013 to their customers. The notice described the product, problem and actions to be taken. The customers were instructed that the Emergency Stop (E-Stop) button be used on the motorized FF WS and CSH WS Buckys for any observed uncontrolled movement as indicated in the user guide. If this movement is observed, please notify Carestream Health, and Carestream will schedule a site visit to resolve the problem. In addition, Carestream Health Inc. will apply a label(s) indicating the location of the E-stop button for customers using the FF WS. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910.
Quantity in commerce: 840 units Total (181 units domestically & 659 units internationally)
Distribution: Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: Catalog Numbers: 1731678, 1731660, 1010990, 1030451, 1016138, 1030477, 1010982, 1030485; Service Code: 7171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0797-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0796-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21
Z-0797-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21
Z-0798-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21

Product code IZL

K091889Class IIDrx-Evolution, Model Vx3733-SysCarestream Health, Inc. / cleared 2009-07-20

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)