Z-0030-2026 Class II Ongoing
FDA device recall Z-0030-2026 was initiated by CHANGE HEALTHCARE CANADA COMPANY on August 13, 2025 and is designated Class II. Reason for recall: Due to software issue, radiology reports may not be fully displayed when viewing. The recall status is ongoing. Affected quantity: 12 programs.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- August 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 programs
Product Description
Change Healthcare Radiology Solutions software version 14.2.2
Reason for Recall
Due to software issue, radiology reports may not be fully displayed when viewing.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Code Information
Version 14.2.2/UDI: (01)17540262030068