Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Check against the official notice below — it lists the full affected range.
Midmark Corporation has recalled 3,624 units of its IQecg Digital ECG system due to a communication anomaly that may cause incorrect electrocardiogram waveforms and inaccurate beats-per-minute calculations. The affected devices are Model/Catalog Numbers 4-000-0061 and 4-000-0062 running Midmark IQecg Plugin software versions v10 or earlier (prior to v10.1.0.18), with serial numbers starting at 480000 up to 4820704. The devices were distributed worldwide, including throughout the United States and Canada.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Reason for recall: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 3624 units Lot/code info: Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg 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: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.