McKesson Cardiology ECG Management — Class II medical device recall Z-1682-2020
Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2020-04-15, distributed nationwide. Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate countin
| Recall number | Z-1682-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY, Richmond, British Columbia, Canada |
| Recall initiated | 2020-02-10 |
| Classified | 2020-04-08 |
| Reported by FDA | 2020-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB |
| Quantity | 51 units |
Product
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1682-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.