Recall Z-1773-2021 ยท LLZ System, Image Processing, Radiological
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
| Date | Apr 19, 2021 |
| Status | Open, Classified |
| Reason | A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. |
| Root cause | Software design |
| Action | On 04/19/21 the firm sent a letter to its consignees with the following instructions: Immediate actions to take to reduce the risk to patient Prior to treating patients, always confirm the correct patient anatomy by reviewing the laterality markers applied during image acquisition. When the issue is detected, the clinician is able to manually adjust the Image Styles in CHEV to accommodate their viewing requirements and/or orient images to standard anatomical position. Product updates that will address the issue Change Healthcare is developing a software update to correct image display of ori |
| Quantity | 33 devices |
| Distribution | US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY. |
| 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 |