Summary
The FDA issued a Class II for Change Healthcare Cardiology Hemo software by A L I Technologies Ltd. Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s)..
Details
Source
Device Recall
External ID
Z-0958-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
Change Healthcare Cardiology Hemo software
Lot/Code Info: Software version/UDI: 14.1.1/(01)17540262100020, 14.2/(01)17540262100037, 14.3/(01)17540262100044, 14.3.2/(01)17540262100051, 15.01/(01)17540262100105, 15.1/(01)17540262100129
Quantity Affected: 204 units
Reason for Recall
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-02
Company
Burnaby
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
A L I Technologies Ltd has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (A L I Technologies Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does A L I Technologies Ltd have FDA actions?
A L I Technologies Ltd has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0958-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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