Recall Z-1508-2021 ยท LLZ System, Image Processing, Radiological
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Enterprise Viewer
| Date | Mar 17, 2021 |
| Status | Open, Classified |
| Reason | Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. |
| Root cause | Software design |
| Action | On 3/15/21 the firm sent an Urgent Field Safety Notice to its customers with the following instructions: Immediate actions to take to reduce the risk to patient When the issue occurs, the initial anchor images are populated in the viewport. The user can select the series identifier in the viewport to display other series for the study. If the initial anchor images in the viewport have been replaced with reference images, the user does not have the ability to view the anchor series. However, the user can reopen the study from the EHR or perform a specific search in CHEV to allow the anchor st |
| Quantity | 28 units |
| Distribution | Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181185 | Change Healthcare Enterprise Viewer Change Healthcare Canada Company, Aug 29, 2018 |