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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

McKesson and Change Healthcare Cardiology Hemo Software Recalled for Medication Risk

Agency Publication Date: January 16, 2025
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Summary

A L I Technologies Ltd is recalling approximately 207 units of McKesson Cardiology Hemo software, Change Healthcare Cardiology Hemo software, and Change Healthcare Cardiology Hemodynamics software due to a defect in the software's autosave mechanism. This software defect can prevent medication records from being properly saved or displayed, which may lead clinical staff to administer incorrect medications or dosages to patients. This voluntary recall was initiated by the firm in December 2024; currently, there have been no reported incidents or injuries associated with this issue.

Risk

The software defect affects how medication information is saved and shown to clinicians. If the autosave mechanism fails, a healthcare provider might inadvertently give a patient the wrong medicine or an improper dose based on incorrect software data, which could lead to serious medical complications in a cardiology setting.

What You Should Do

  1. This recall affects McKesson Cardiology Hemo software, Change Healthcare Cardiology Hemo software, and Change Healthcare Cardiology Hemodynamics software distributed to hospitals and clinics across 41 US states and several international locations.
  2. Check the specific software version and Unique Device Identifier (UDI) currently installed on your facility's cardiovascular information system. See the Affected Products section below for the full list of affected codes.
  3. Clinical staff should stop using the affected software versions for medication administration tasks until the manufacturer provides a validated fix or update.
  4. Hospital administrators and IT supervisors should contact A L I Technologies Ltd or their authorized software distributor to coordinate the necessary software updates or corrections.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: McKesson Cardiology Hemo software
Model / REF:
13.1.2
13.2.1
14
UDI:
80010939050010
80010939050027

1 unit affected; Recall #: Z-0957-2025

Product: Change Healthcare Cardiology Hemo software
Model / REF:
14.1.1
14.2
14.3
14.3.2
15.01
15.1
UDI:
17540262100020
17540262100037
17540262100044
17540262100051
17540262100105
17540262100129

204 units affected; Recall #: Z-0958-2025

Product: Change Healthcare Cardiology Hemodynamics software
Model / REF:
15.01
UDI:
17540262100129

2 units affected; Recall #: Z-0959-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96025
Status: Active
Manufacturer: A L I Technologies Ltd
Sold By: Hospitals; Cardiology clinics
Manufactured In: Canada
Units Affected: 3 products (1 unit; 204 units; 2 units)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.