Recall Z-3012-2026

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 taken

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.