Z-3013-2026Class II

Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin...

Name: Z-3013-2026 Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin...
Creator: Midmark Corporation
Published: 2026-07-20
License: https://open.fda.gov/license/

Midmark Corp / initiated 2026-07-20 / Open, Classified / root cause: software

FDA source

Midmark Corporation began a recall of 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 on 2026-07-20. FDA classified it as Class II and gives the reason as "A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3013-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-20
Posted: 2026-08-25
Recalling firm: Midmark Corp
Product: 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.
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Root cause tag: software
FDA 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, 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].
Quantity in commerce: 3624 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3013-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3012-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-25
Z-3013-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-25

Product code DRG

K220526Class IIHd+12, Hd+15Cardioline S.P.A / cleared 2023-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)