Z-0237-2024 Class II Ongoing
FDA device recall Z-0237-2024 was initiated by CHANGE HEALTHCARE CANADA COMPANY on October 12, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 282 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- October 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 282 units
Product Description
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Reason for Recall
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.
Distribution Pattern
US, Canada, Ireland, Saudi Arabia, France, UK
Code Information
UDI/DI 17540262030020