Z-1877-2013Class II

Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed...

Name: Z-1877-2013 Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed...
Creator: Carestream Health Inc.
Published: 2013-06-03
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-06-03 / Terminated

FDA source

Carestream Health Inc. began a recall of Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for... on 2013-06-03. FDA classified it as Class II and gives the reason as "Due to potential for an x-ray exposure technique change". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1877-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-03
Posted: 2013-08-12
Terminated: 2014-01-29
Recalling firm: Eastman Kodak Company
Product: Carestream DRX Evolution System, X-Ray System --- 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: KPR System, X-Ray, Stationary
Reason for recall: Due to potential for an x-ray exposure technique change.
FDA root cause: Radiation Control for Health and Safety Act
Action: Carestream will make the correction which includes the installation of a SW patch to the affected customer sites, and to any other affected customer sites utilizing the DRX Evolution with V5. 5 SW outside of the US. --- Once receiving FDA approval on the corrective action plan, the correction will be implemented to all affected devices at identified customer sites: 1. A notification letter was sent to all customers identifying the issue and highlighting the approved procedures of the Corrective Action Plan. The letters were sent on 8/16/13 via Certified Mail, Return Receipt Requested. 2. Carestream Health will contact the customer to schedule a service visit to install software updates to correct this issue. The installation time will be approximately one hour. 3. As stated in the customer notification letter, this software update will be provided to the customer at no expense. 4. All software updates are estimated to be completed within 1-3 months. 5. Carestream Health will provide monthly progress reports on the effectiveness of the plan, including the number of units corrected. Further questions please call (800) 328-2910.
Quantity in commerce: US: 49 units; Foreign: 183 units (revised)
Distribution: Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Product codes and lots: Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1877-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1877-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-12

Product code KPR

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)