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Midmark Digital ECG HD+12, HD+15, Model/Catalog Number:… recallZ-3013-2026 · Midmark Corporation · initiated Jul 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Midmark Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

FDA root cause category: Software design

What the company is doing

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, follow the temporary workaround instructions provided in Appendix A. Midmark will contact your facility with additional information regarding verification of your software installation and implementation of this Field Corrective Action. Product Correction Midmark has developed a corrected version of the IQecg Plugin software that addresses the issue described in this notification and is implementing a Field Corrective Action for affected software versions. No immediate action is required to contact Midmark at this time. Midmark will contact your facility to verify the IQecg Plugin software version(s) installed on your workstations and coordinate the appropriate correction process. Depending on your facility's configuration and support requirements, the correction may be completed using Midmark-provided installation instructions or with assistance coordinated by Midmark Technical Support or an authorized service provider. Contact Information Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact the Technical Service Team at 1.844.856.1230, option 2, or email [email protected].

Recall details

Recall number
Z-3013-2026
Status
Open, Classified
Initiated by the company
Jul 20, 2026
Posted by the FDA
Aug 25, 2026
Recalling firm
Midmark Corporation
Quantity
3624 units
Product code
DRG
FDA submissions
K220526
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

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.

Code information (models, lots, serial numbers)

Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99404).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page