Recall Z-0774-2014 ยท KPR System, X-Ray, Stationary
Carestream Health Inc.
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 statio
| Date | Jan 29, 2014 (initiated Aug 20, 2013) |
| Status | Terminated |
| Reason | 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. |
| 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 inst |
| Quantity | 4 units |
| Distribution | Nationwide Distribution including TX, IL, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.