The Recall Desk
HighFDA (Devices)·Z-2072-2025·Announced 2025-07-09

Cardiology hemodynamics software update may cause unexpected system shutdowns

Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled because, following complaints, a software update may cause the software to unexpectedly shut down.

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: Risk-of-harm product: software used during cardiac procedures may shut down unexpectedly in use, with no patient harm reported in the source.

Plain-English summary

Change Healthcare Cardiology Hemodynamics Software, version 15.0.1, UDI (01)17540262100129, is being recalled. The action covers 4 systems.

The stated reason is that, due to complaints, a software update may cause the software to unexpectedly shut down. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States across Alabama, Arkansas, California, Florida, Kentucky, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, Pennsylvania, Tennessee, Texas and Washington, and to Australia, Canada, Germany, Great Britain, Ireland, Israel and New Zealand.

Facilities should identify affected installations using the software version and UDI above and follow the instructions issued by the manufacturer.

The recalled product

Product
Change Healthcare Cardiology Hemodynamics Software
Manufacturer
CHANGE HEALTHCARE CANADA COMPANY
Category
Medical Device — Cardiology software
Hazard
  • software-shutdown
  • hemodynamics
  • in-use-failure
  • class-ii

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 (1)

  • Software version: 15.0.1/UDI: (01)17540262100129

Distribution

Distributed nationwide across the United States.

Related recalls

Same category