Class 2 Device Recall Midmark Digital ECG

• Date Initiated by Firm: July 20, 2026
• Date Posted: August 25, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3013-2026
• Recall Event ID: 99404
• 510(K)Number: K220526
• Product Classification: Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
• 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.
• Code Information: 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
• FEI Number: 1523530
• Recalling Firm/ Manufacturer: Midmark Corporation; 60 Vista Dr; Versailles OH 45380-9488
• For Additional Information Contact: Midmark Service Operations; 844-8561230 Ext. 2
• Manufacturer Reason for Recall: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
• FDA Determined 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 techsupport@midmark.com.
• Quantity in Commerce: 3624 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DRG