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.
Check against the official notice below — it lists the full affected range.
Midmark Corporation has recalled its Digital ECG HD+12 and HD+15 devices due to a software issue affecting the IQecg Plugin versions starting with v10 and prior to v10.1.0.18. The issue may cause incorrect electrocardiogram waveforms to display and result in inaccurate beats-per-minute calculations for patients. The recall affects 3,624 units that were distributed worldwide, including throughout the US and Canada.
The source document does not specify a remedy or corrective action 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 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.