Recall Z-2449-2015 ยท KPR System, X-Ray, Stationary
Carestream Health Inc
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
| Date | Aug 22, 2015 (initiated Aug 7, 2015) |
| Status | Terminated |
| Reason | Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph. |
| Root cause | Software design |
| Action | Carestream sent an Urgent Medical Device Correction letters dated July 29, 2015 and Customer Notification Acknowledgement Forms to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Carestream will update the software on your device to correct this issue. For questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number. |
| Quantity | Domestic: 76 units, Foreign: 160 units |
| Distribution | Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141837 | DRX-EVOLUTION Carestream Health, Inc., Mar 11, 2015 |