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. Recall

Check Your Product

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

Reason for Recall

As stated by FDA

A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.

Recommended Action

Per FDA guidance

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 orientation, image inversion and window level information from Image Styles. 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. Change Healthcare Customer Support: 1-800-663-2533 Menu Option 3 (CHEV)