Midmark IQecg Digital ECG
Midmark recalls IQecg Digital ECG over incorrect ECG waveforms and BPM calculations.
Contact Midmark Corporation to obtain the software update (v10.1.0.18 or later) that corrects the communication anomaly. Do not use the device until the update is applied.
Recall at a glance
- Quantity recalled
- 3624 units
Why it was recalled
Midmark Corporation is recalling the IQecg Digital ECG due to a communication anomaly that may result in incorrect electrocardiogram waveforms and inaccurate beats-per-minute calculations. The affected models are 4-000-0061 and 4-000-0062, with software versions starting with v10 and prior to v10.1.0.18.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Lot code: v10, v10.1.0.18
| Product | Recall # | UDI-DI |
|---|---|---|
| Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. | Z-3013-2026 | 00841709121319, 08056732652491 |
| 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. | Z-3012-2026 | 00841709100581, 00841709100321, 00841709100895, 00841709100901 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-26 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification