FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: 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.
- Recall number
- Z-1773-2021
- 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.
- Status
- Open, Classified
- Initiated
- 2021-04-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
- 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
- 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.
- Lot, serial or model codes
- Software version 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