Change Healthcare Cardiology Hemodynamics software recall: Software Issue
Change Healthcare Cardiology Hemodynamics software
Why was Change Healthcare Cardiology Hemodynamics software recalled?
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
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 15.01/UDI:(01)17540262100129
- Product
- Change Healthcare Cardiology Hemodynamics software
- Recalling firm
- A L I Technologies Ltd
- Quantity
- 2 units
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.
- Recall date
- January 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)