Device Recall Carestream DRX Evolution System (Standard Q) 의 리콜

Recall

67060

Class 2

Z-0774-2014

2013-08-20

2014-01-29

Terminated

United States

2016-06-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124636

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.

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.