FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Radiology Solutions software version 14.2.2
- Recall number
- Z-0030-2026
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Product
- Change Healthcare Radiology Solutions software version 14.2.2
- Status
- Open, Classified
- Initiated
- 2025-08-13
- Posted
- 2025-10-02
- Terminated
- not on file
- Reason
- Due to software issue, radiology reports may not be fully displayed when viewing.
- Root cause
- Software Design Change
- Action
- On August 13, 2025, Change Healthcare Canada Company issued a Urgent Medical Device Recall notification to affected consignees via Email. Chang Healthcare asked consignees to take the following actions: 1. Generate an audit report to list all studies accessed since CHRS 14.2.2 client was first installed. 2. Re-evaluate the identified cases and take any necessary follow-up measures to confirm that each patient s diagnosis and management remain appropriate. 4. This notice must be distributed to all personnel within your organization who need to be aware 5. To ensure effectiveness of any required corrective actions, please maintain awareness of this RECALL until the issue has been fully resolved. 6. Please notify our Customer Support department at: 1-800-663-2533 that you have read and understood the recall notice and schedule your product update to be installed on your system.
- Quantity
- 12 programs
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
- Lot, serial or model codes
- Version 14.2.2/UDI: (01)17540262030068
- 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