FDA Enforcement
Class II
Ongoing
Change Healthcare Cardiology Hemodynamics software
Recall: Z-0959-2025
·
Reported January 22, 2025
Enforcement
- Recall Number
- Z-0959-2025
- Event ID
- 96025
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- A L I Technologies Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2025
- Initiation Date
- December 2, 2024
- Classification Date
- January 16, 2025
- Address
- 3700 Gilmore Way Suite 207, Burnaby, N/A, Canada
Description
Change Healthcare Cardiology Hemodynamics software
Reason
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Code Info
Software version 15.01/UDI:(01)17540262100129
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.
Quantity
2 units