Z-0774-2014Class II

Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed...

Name: Z-0774-2014 Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed...
Creator: Carestream Health Inc.
Published: 2013-08-20
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-08-20 / Terminated

FDA source

Carestream Health Inc. began a recall of Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays... on 2013-08-20. FDA classified it as Class II and gives the reason as "Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0774-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-20
Posted: 2014-01-29
Terminated: 2016-06-28
Recalling firm: Eastman Kodak Company
Product: Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. 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 wallstandbucky to complete x-ray exposures.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.
FDA root cause: Radiation Control for Health and Safety Act
Action: The Center for Devices and Radiological Health (CDRH) understands that the CAP (Corrective Action Plan) involving 4 units will consist of the following: a. Distribution of a letter to all affected customers informing them of the issue, how to prevent the issue including a reminder of instructions for proper x-ray system setup and operation found in the User Manual. The letter will also include actions to be taken by Carestream to correct the issue. This communication will be marked and distributed pursuant to the requirements of 21 CFR 1003.21. b. The next stage of correction will be the installation of a software patch to any potentially affected customer sites. The software patch has been developed to prevent the system from allowing an exposure when the bucky and detector are not selected. This patch has been verified and proven successful prior to rollout in manufacturing. Once receiving FDA approval on the corrective action plan, the correction will be implemented within the US to all affected devices at identified customer sites. c. The completion of the Corrective Action Plan, once approved, is expected to take approximately 3 months. d. Carestream will provide FDA with a report demonstrating effective closure of the activity. CDRH approves the draft of the customer notification letter and CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions please call 585-627-6473.
Quantity in commerce: 4 units
Distribution: Nationwide Distribution including TX, IL, and GA.
Product codes and lots: Serial Numbers 5049, 5073, 5133, 5162

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0774-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0774-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-29

Product code KPR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)