Recall Z-0959-2025— A L I Technologies Ltd
Class II · Ongoing
Class II FDA medical device recall by A L I Technologies Ltd, initiated 2024-12-02. It names one FDA 510(k) clearance: K230881. Product: Change Healthcare Cardiology Hemodynamics software. Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s)..
- Recalling firm
- A L I Technologies Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-02
- Firm location
- Burnaby, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Change Healthcare Cardiology Hemodynamics software
Reason for recall
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Data sourced from openFDA. This site is unofficial and independent of the FDA.