DeviceSignal · Recall classified
Midmark Corporation
FDA classified a device recall on 2026-08-25 · Class II · Z-3013-2026
EventRecall classified
Effective2026-08-25
ClassificationClass II
On 2026-08-25 the FDA classified a device recall from Midmark Corporation as Class II. Product: Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version…. Recall Z-3013-2026. The firm initiated it on 2026-07-20. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3013-2026
- Classification
- Class II
- Classified on
- 2026-08-25
- Initiated on
- 2026-07-20
- Firm
- Midmark Corporation
- Reason
- A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3013-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
3dab864eb238c3aafec0c0784ddb0bad06cb2976b54a19794edcdd86e34a6264- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)