FDA Device recall Z-1682-2020
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
- FDA Device
- Class II
- ongoing
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management by Change Healthcare Canada, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1682-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-02-10 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Change Healthcare Canada |
| Distribution | US |
Product
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
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
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1682-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.