Change Healthcare Cardiology Software May Shutdown Unexpectedly After Update
Change Healthcare Cardiology Software may unexpectedly shut down after a recent update. The FDA has recalled 29 systems following complaints.
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 involving cardiology software. Per the severity rubric, the recall meets the criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a High (Score 3) rating. No deaths, hospitalizations, or illnesses have been reported.
Plain-English summary
Change Healthcare's Cardiology Hemo Software is being recalled after complaints that a recent software update may cause the application to shut down unexpectedly. This Class II recall affects 29 systems distributed nationwide and in several countries including Australia, Canada, Germany, Great Britain, Ireland, Israel, and New Zealand.
Users of the affected software should be aware of this issue and contact Change Healthcare Canada Company if they experience unexpected shutdowns or related problems.
The recalled product
- Product
- Change Healthcare Cardiology Hemo Software
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Hazard
- unexpected-shutdown
- 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 (1)
- Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105
Distribution
Distributed nationwide across the United States.
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