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U.S. Department of Health and Human Services

Class 2 Device Recall Carestream DRX Evolution System (Standard Q)

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 Class 2 Recall
Carestream DRX Evolution System (Standard Q)
see related information
Date Posted January 29, 2014
Recall Status1 Open
Recall Number Z-0774-2014
Recall Event ID 67060
Premarket Notification
510(K) Number
Product Classification System, X-Ray, Stationary - Product Code KPR
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.
Code Information Serial Numbers 5049, 5073, 5133, 5162
Recalling Firm/
Carestream Health Inc.
150 Verona St
Rochester, New York 14608-1733
Manufacturer 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 Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = CARESTREAM HEALTH, INC.