The Recall Desk
HighFDA (Devices)·Z-0958-2025·Announced 2025-01-22

Change Healthcare Cardiology Hemo software autosave defect recall

A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of software that poses a risk of medication errors due to a defect in the autosave mechanism. No illnesses or injuries have been reported; the hazard is potential, not realized.

Plain-English summary

Change Healthcare Cardiology Hemo software versions 14.1.1 through 15.1 is being recalled due to a defect in the autosave mechanism.

The software defect may result in clinicians administering incorrect medications to patients. This poses a potential risk of medication errors in clinical settings where the software is used.

The recall affects 204 units distributed nationwide across all U.S. states and internationally in Australia, Israel, Canada, Germany, Ireland, and the United Kingdom. Affected software versions include 14.1.1, 14.2, 14.3, 14.3.2, 15.01, and 15.1.

Healthcare facilities and clinicians using affected versions of Change Healthcare Cardiology Hemo software should contact A L I Technologies Ltd for instructions on obtaining a corrected version. Verify your software version matches one of the affected versions listed in the recall.

The recalled product

Product
Change Healthcare Cardiology Hemo software
Manufacturer
A L I Technologies Ltd
Category
Medical Device — Cardiology Software
Hazard
  • medication-error
  • software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category