Midmark Corporation: Transmitters And Receivers, Physiological Signal, Radiofrequency
Recall Summary Midmark Corporation is recalling certain Digital ECG HD+ heart monitoring devices (models 4-000-0080) with software version 10 and earlier due to a communication problem that may display incorrect heart rhythm readings or inaccurate heart rate measurements. The devices are used in medical settings and were distributed nationwide in the US and Canada. This is a Class II recall, meaning the problem could result in serious health consequences but is not likely to cause death.
- Recalling firm
- Midmark Corporation
- 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.
- Reason
- A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1cbfeb7f-9240-4363-8c40-d479fcbc14c3