Change Healthcare Cardiology Hemo software
Reported: January 22, 2025 Initiated: December 2, 2024 #Z-0958-2025
Product Description
Change Healthcare Cardiology Hemo software
Reason for Recall
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Details
- Recalling Firm
- A L I Technologies Ltd
- Units Affected
- 204 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.
- Location
- Burnaby
Frequently Asked Questions
What product was recalled? ▼
Change Healthcare Cardiology Hemo software. Recalled by A L I Technologies Ltd. Units affected: 204 units.
Why was this product recalled? ▼
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0958-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11