Change Healthcare Cardiology ECG Software Recalled for Heart Rate Estimation Errors
Change Healthcare Canada Company is recalling McKesson and Change Healthcare Cardiology ECG Management software due to potential inaccurate heart rate estimation in Sequential ECG format.
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: The recall is classified as FDA Class II, and the hazard involves potential inaccurate heart rate estimation, which is a risk-of-harm product issue where injury has not yet been reported.
Plain-English summary
Change Healthcare Canada Company is recalling McKesson Cardiology ECG Management and Change Healthcare Cardiology ECG Management software. The recall involves 51 units of software distributed in the United States, Canada, and the United Kingdom. The affected software versions include McKesson versions 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, and 14.0 HF2, as well as Change Healthcare versions 14.1.1 and 14.2.
The recall is issued because inaccurate estimation of the heart rate may occur when users estimate heart rate by counting grid squares using the Sequential ECG format. This issue is classified as an FDA Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
Healthcare providers and facilities using these specific software versions should contact the recalling firm for instructions on how to proceed. Users should be aware of the potential for heart rate estimation errors when using the Sequential ECG format.
The recalled product
- Product
- McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Hazard
- Affected units
- 51
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 (7)
- McKesson Cardiology Software Versions: 13.2.1 HF1
- 13.2.1 HF2
- 14.0
- 14.0 HF1
- 14.0 HF2
- Change Healthcare Software Versions: 14.1.1
- 14.2
Distribution
Distributed nationwide across the United States.
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