Recall Z-0072-2021 ยท LLZ System, Image Processing, Radiological
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Radiology Solutions 14.0
| Date | Aug 25, 2020 |
| Status | Terminated |
| Reason | Software defect which may potentially result in one or more images missing in a study |
| Root cause | Process design |
| Action | Change Healthcare Canada Company issued Urgent Field Safety Notice on 08/25/2020. It states the following: 1. The customer should ensure radiologists and technologists are aware of the potential that the study may be missing images or DICOM objects, so that they carefully review any study where the above listed situations may be present in the workflows. 2. Change Healthcare has identified a configuration change that will prevent the deletion of impacted images. The customer should contact Change Healthcare Customer Support to ensure this configuration is place. Recommended actions to take |
| Quantity | 5 devices |
| Distribution | Domestic distribution to VT, MS, WV, NE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140909 | MCKESSON RADIOLOGY Mckesson Medical Imaging Company, Jul 2, 2014 |