CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Enterprise Viewer Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

Recommended Action

Per FDA guidance

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 study series to display in the viewport. In addition, the user can change the timeline filter to omit the scheduled study, which would allow the anchor study to display in the timeline. Product updates that will address the issue Change Healthcare has developed a software update to correct this issue. Recommended actions to take on potentially affected data We strongly encourage customers receiving this Urgent Field Safety Notice to immediately contact Change Healthcare Customer Support to: 1) Acknowledge they have read and understood this Urgent Field Safety Notice; and, 2) Arrange the installation of software update.

Distribution

As reported by FDA

AK, AZ, CA, FL, HI, IL, IN, IA, KY, MI, NE, NY, OH, PA, TX, WA, WI, WY