Recall Z-3012-2026 ยท DPS Electrocardiograph
Midmark Corporation
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
| Date | Aug 25, 2026 (initiated Jul 20, 2026) |
| Status | Open, Classified |
| Reason | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| Root cause | Software design |
| Action | n URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/17/26 was sent to customers. Safety Instructions Until the corrected IQecg Plugin software has been installed, for electrocardiogram tracings that reflect a fast heart rate (tachycardia), Midmark recommends performing a manual clinical assessment of the patient's heart rate prior to initiating therapeutic intervention. This bedside verification should be used to confirm the accuracy of the displayed ECG heart rate before making clinical management decisions based on the device's displayed value. If this issue is encountered, follo |
| Quantity | 3624 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103640 | MIDMARK IQECG Brentwood Medical Technology Corp., Mar 22, 2011 |