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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 Viewersee related information
Date Initiated by FirmMarch 17, 2021
Create DateApril 28, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1508-2021
Recall Event ID 87616
510(K)NumberK181185 
Product Classification System, image processing, radiological - Product Code LLZ
ProductChange Healthcare Enterprise Viewer
Code Information Change Healthcare Enterprise Viewer 2.0 and 2.1
FEI Number 3003757840
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada
Manufacturer Reason
for Recall		Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce28 units
DistributionDomestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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