Z-0959-2025 Class II Ongoing
FDA device recall Z-0959-2025 was initiated by A L I Technologies Ltd on December 2, 2024 and is designated Class II. Reason for recall: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Change Healthcare Cardiology Hemodynamics software
Reason for Recall
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Distribution Pattern
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.
Code Information
Software version 15.01/UDI:(01)17540262100129