Recall archive / FDA device enforcement
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information managemen... — FDA record Z-0237-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 12, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
- Reason
- Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.
- Classification
- Class II
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Quantity
- 282 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0237-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 17540262030020 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US, Canada, Ireland, Saudi Arabia, France, UK
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 15, 2023
- Recall initiation date
- Oct 12, 2023
- Center classification date
- Nov 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.