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U.S. Department of Health and Human Services

Class 2 Device Recall Change Healthcare Enterprise Viewer

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  Class 2 Device Recall Change Healthcare Enterprise Viewer see related information
Date Initiated by Firm April 19, 2021
Create Date June 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-1773-2021
Recall Event ID 87891
510(K)Number K181185  
Product Classification System, image processing, radiological - Product Code LLZ
Product 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.
Code Information Software version 2.0 and 2.1.
Recalling Firm/
10711 Cambie Rd Suite 130
Richmond Canada
Manufacturer Reason
for Recall
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
FDA Determined
Cause 2
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 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)
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Change Healthcare Canada Company