FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Enterprise Viewer
- Recall number
- Z-1508-2021
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Product
- Change Healthcare Enterprise Viewer
- Status
- Open, Classified
- Initiated
- 2021-03-17
- Posted
- not on file
- Terminated
- not on file
- Reason
- Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
- 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
- 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
- Lot, serial or model codes
- Change Healthcare Enterprise Viewer 2.0 and 2.1
- 510(k) numbers
- ["K181185"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3003757840
- Firm city
- Richmond
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28