Midmark recalls specific ECG models with outdated software that may cause incorrect heart rhythm readings. Affected units include HD+12 and HD+15 models with software versions up to v10.1.0.18. Update software to fix the issue.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Midmark is recalling certain ECG devices that have software versions up to v10.1.0.18. These devices may show incorrect heart rhythm readings, which could lead to misdiagnosis if used for medical purposes.
The software may display incorrect electrocardiogram waveforms and inaccurate heart rate calculations. This could lead to misdiagnosis if the device is used for medical purposes, but does not cause physical harm directly.
Healthcare professionals using Midmark Digital ECG HD+12 or HD+15 models with software versions up to v10.1.0.18 are most at risk. Patients using these devices for medical monitoring could also be affected.
Check for the model number 4-000-0080 on the device. The software version should be up to v10.1.0.18. Serial numbers listed include 7817519, 7817645, L1130587, V2967564.
Install the updated software version v10.1.0.18 or later to fix the communication anomaly.
No, you can continue using it but you must update the software to the latest version to prevent incorrect readings.
Software versions starting with v10 and up to but not including v10.1.0.18.
Check the model number (4-000-0080) and software version on your device. Affected units have serial numbers listed in the recall notice.
We’ve drafted a message you can send Midmark to request your refund or repair — edit it as you like.
Subject: Recall Z-3013-2026 — Midmark Midmark Hello, I own a Midmark that is covered by recall Z-3013-2026 from Midmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
