Z-1508-2021Class II

Change Healthcare Enterprise Viewer

Name: Z-1508-2021 Change Healthcare Enterprise Viewer
Creator: Change Healthcare Canada Company
Published: 2021-03-17
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2021-03-17 / Open, Classified / root cause: software

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of Change Healthcare Enterprise Viewer on 2021-03-17. FDA classified it as Class II and gives the reason as "Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1508-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-17
Posted: 2021-04-28
Recalling firm: Change Healthcare Canada Company
Product: Change Healthcare Enterprise Viewer
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 28 units
Distribution: Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA
Product codes and lots: Change Healthcare Enterprise Viewer 2.0 and 2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1508-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1508-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-28

Product code LLZ

K181185Class IIChange Healthcare Enterprise ViewerChange Healthcare Canada Company / cleared 2018-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)