Z-1773-2021Class II

Change Healthcare Enterprise Viewer -

Name: Z-1773-2021 Change Healthcare Enterprise Viewer -
Creator: Change Healthcare Canada Company
Published: 2021-04-19
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2021-04-19 / Open, Classified / root cause: software

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of 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... on 2021-04-19. FDA classified it as Class II and gives the reason as "A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV". 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-1773-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-19
Posted: 2021-06-02
Recalling firm: Change Healthcare Canada Company
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Software version 2.0 and 2.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1773-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1773-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-09	2021-06-02

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)