Class II — CHANGE HEALTHCARE CANADA COMPANY
| Recalling firm | Change Healthcare Canada Company |
|---|---|
| Registered facility | CHANGE HEALTHCARE CANADA COMPANY (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management |
| Quantity | 51 units |
| Distribution | Distribution US nationwide, Canada and the United Kingdom |
| Initiated | 2020-02-10 |
| Classified | 2020-04-08 |
| Recall number | Z-1682-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CHANGE HEALTHCARE CANADA COMPANY (Z-1682-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85068/
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