CLASS II ONGOING Device recall · Reported 15 Apr 2020 · FDA Enforcement Report
McKesson Cardiology ECG Management recalled by Change Healthcare Canada
Change Healthcare Canada is recalling McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management, distributed nationwide in the US. The recall was initiated on 10 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1682-2020
- FDA event ID
- 85068
- Recalling firm
- Change Healthcare Canada, Richmond, British Co
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Feb 2020
- FDA classified
- 8 Apr 2020
- Reported
- 15 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Patient Monitors
Timeline
| 10 Feb 2020 | Recall initiated by company | |
| 8 Apr 2020 | Classified by FDA | +58 days |
| 15 Apr 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
Product as listed by the FDA
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Where it was distributed
Distribution US nationwide, Canada and the United Kingdom
Questions about this recall
Why was it recalled?
Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
Which lots are affected?
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
Where was it sold?
Distribution US nationwide, Canada and the United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Change Healthcare Canada
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|---|---|---|---|---|---|
| Device | CLASS II | Change Healthcare Radiology Solutions recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemodynamics recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Cardiology Hemo recalled by Change Healthcare Canada | Change Healthcare Canada | Labeling Errors | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Labeling Errors | Nationwide |
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| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
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