Change Healthcare Cardiology Hemodynamics Software recall: Software Issue
Change Healthcare Cardiology Hemodynamics Software
Why was Change Healthcare Cardiology Hemodynamics Software recalled?
Due to complaints, software update may cause software to unexpectedly shutdown.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version: 15.0.1/UDI: (01)17540262100129
- Product
- Change Healthcare Cardiology Hemodynamics Software
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Quantity
- 4 systems
- 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.
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)