FDA Medical devices recall ·
Change Healthcare Cardiology Hemodynamics Software recall
- Recall number
- Z-2072-2025
- Date
- (initiated May 22, 2025)
- Company / brand
- Change Healthcare Canada Company
10711 Cambie Rd Suite 130, Richmond, Canada - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Change Healthcare Cardiology Hemodynamics Software
Why was it recalled?
Due to complaints, software update may cause software to unexpectedly shutdown.
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
Software version: 15.0.1/UDI: (01)17540262100129
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.
States: Alabama Arkansas California Florida Kentucky Missouri Mississippi Nebraska New Hampshire New Jersey Pennsylvania Tennessee Texas Washington
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-2072-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.