Health Canada Flags Midmark IQecg Digital ECG Software Recall 2026

Health Canada has published a Type II health product recall covering Midmark Corporation’s IQecg Digital ECG plugin software, warning that older versions of the program may produce incorrect ECG waveforms and inaccurate heart-rate calculations. The recall is listed under identification number RA-82412 and is aimed at healthcare audiences rather than the general public.

The department lists the recall date as October 15, 2026. The notice was first published on July 28, 2026, and the record was last updated on October 19, 2026. Midmark, the manufacturer named in the notice, is based at 60 Vista Drive in Versailles, Ohio, in the United States.

Regulatory Response

Health Canada classifies the action as a Type II recall and files it under medical devices in the cardiovascular category. The issue is described as a performance problem with the device software. The notice is published by Health Canada’s Medical devices program and is addressed to healthcare professionals and facilities that use the product.

The listed advice is short. Health Canada tells those who need more information to contact the manufacturer. The notice also says Midmark will coordinate installation of the corrected software.

Products Affected by This Recall

The recall covers three product listings. Each is identified by software version rather than by a traditional lot or serial number, and each applies to software released before version 10.1.0.18.

• IQecg Digital ECG – model or catalogue number 4-000-0061 – software prior to v10.1.0.18
• IQecg Digital ECG – model or catalogue number 4-000-0062 – software prior to v10.1.0.18
• IQecg – Serial Version – model or catalogue number 4-000-0060 – software prior to v10.1.0.18

In practical terms, any clinic or facility running one of these models with a software build older than v10.1.0.18 falls within the scope of the recall. Facilities should check the installed software version against the figures above.

What Went Wrong?

According to Health Canada, the affected IQecg plugin software may produce incorrect ECG waveforms and inaccurate heart-rate calculations. An electrocardiogram is a tool clinicians use to assess heart activity, and the heart rate shown on screen can inform treatment decisions. That is why the notice addresses what users should do before acting on the displayed rate.

The notice does not describe the underlying cause of the software fault. It does not say how many units are affected, and it does not report any injuries or adverse events. Those details are not included in the public record, so they are not covered here.

Who Should Be Concerned

The audience for this recall is listed as healthcare. That means the notice is directed at professionals and organizations that use the IQecg Digital ECG software as part of patient assessment. Patients are not asked to take any action themselves, but they may wish to ask their provider whether the equipment used in their care is affected.

The notice is published for Canada, but the manufacturer is based in the United States. The record does not list specific provinces, distributors or dates of sale, so users are advised to rely on the model numbers and software version above to determine whether their equipment is covered.

What Consumers Need to Do Now

Health Canada’s guidance for users is direct. Until corrected software is installed, users should manually assess the patient’s heart rate before initiating therapeutic intervention. If the issue occurs, they should use the temporary workaround referenced in the notice.

• Check whether your facility uses IQecg Digital ECG models 4-000-0060, 4-000-0061 or 4-000-0062.
• Confirm whether the installed software is older than v10.1.0.18.
• Manually assess the patient’s heart rate before starting any therapeutic intervention.
• Use the temporary workaround if the issue occurs.
• Contact Midmark for additional information and to arrange installation of the corrected software.

The public notice does not spell out the steps of the temporary workaround or give a contact phone number or email address for Midmark. Facilities should contact the manufacturer directly for those details.

Quick Facts

• Recall number: RA-82412
• Recall class: Type II
• Recall date: 2026-10-15
• Originally published: 2026-07-28
• Last updated: 2026-10-19
• Manufacturer: Midmark Corporation, Versailles, Ohio
• Issue type: Medical devices – Performance

From the Agency

In its summary, Health Canada states that the affected IQecg plugin software may produce incorrect ECG waveforms and inaccurate heart-rate calculations. It adds that users should manually assess the patient’s heart rate before initiating therapeutic intervention until corrected software is installed, and that Midmark will coordinate installation of the corrected software.

Health Canada also invites the public to subscribe to email updates about new and updated recalls and safety alerts, and to report any health or safety concern through its official reporting channel. Healthcare providers who encounter problems with the IQecg Digital ECG should report them through that channel and keep their facility’s records of the affected software version for reference.

Because the notice has been updated since its original publication, facilities are encouraged to review the official Health Canada page for the latest wording before taking action.