FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Radiology Solutions 14.0
- Recall number
- Z-0072-2021
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Product
- Change Healthcare Radiology Solutions 14.0
- Status
- Terminated
- Initiated
- 2020-08-25
- Posted
- not on file
- Terminated
- 2021-02-16
- Reason
- Software defect which may potentially result in one or more images missing in a study
- Root cause
- Process design
- Action
- Change Healthcare Canada Company issued Urgent Field Safety Notice on 08/25/2020. It states the following: 1. The customer should ensure radiologists and technologists are aware of the potential that the study may be missing images or DICOM objects, so that they carefully review any study where the above listed situations may be present in the workflows. 2. Change Healthcare has identified a configuration change that will prevent the deletion of impacted images. The customer should contact Change Healthcare Customer Support to ensure this configuration is place. Recommended actions to take on potentially affected data: Change Healthcare 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 configuration change, and 3) Arrange the installation of software update. Change Healthcare Customer Support for US/Canada: 1-800-663-2553 This notice must be distributed to all personnel within your organization who need to be aware of this Urgent Field Safety Notice. Customers should alert other affiliated parties that may be affected by this Urgent Field Safety Notice. To ensure effectiveness of any required corrective actions, please maintain awareness of this Urgent Field Safety Notice until the issue has been fully resolved.
- Quantity
- 5 devices
- Distribution
- Domestic distribution to VT, MS, WV, NE
- Lot, serial or model codes
- All Model number 14.0 UDI (01)17540262030020(10)140000
- 510(k) numbers
- ["K140909"]
- 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