Recall Z-1682-2020 ยท DQK Computer, Diagnostic, Programmable
CHANGE HEALTHCARE CANADA COMPANY
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
| Date | Feb 10, 2020 |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | Change Healthcare Canada Company notified customers on about 02/10/2020 via "Urgent Field Safety Notice" letter. Customers were informed of an issue whereby users who are estimating heart rate by counting grid squares, may assume that the Sequential ECG format is presented on a scale of 25 mm/sec and thereby may inaccurately estimate the heart rate value. Instructions included that the Simultaneous ECG format can be used rather than the Sequential ECG format, until the software is updated and the Sequential ECG format option can be used while maintaining awareness to the scale bar on the s |
| Quantity | 51 units |
| Distribution | Distribution US nationwide, Canada and the United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113515 | HORIZON CARDIOLOGY ECG MANAGEMENT Mckesson Israel , Ltd., Mar 16, 2012 |