FDA Medical devices recall ·
Change Healthcare Radiology Solutions software version 14.2.2 recall
- Recall number
- Z-0030-2026
- Date
- (initiated August 13, 2025)
- Company / brand
- Change Healthcare Canada Company
10711 Cambie Rd Suite 130, Richmond, N/A, Canada - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12 programs
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Change Healthcare Radiology Solutions software version 14.2.2
Why was it recalled?
Due to software issue, radiology reports may not be fully displayed when viewing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Version 14.2.2/UDI: (01)17540262030068
Distribution
Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
States: Alabama Arkansas California Florida Indiana Louisiana Massachusetts New Jersey Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0030-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.