Official recall notice
FDA DeviceClass IINotable
FDA Recall: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001.
- Recall date
- 2026-06-10
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
Recommended action
What to do
16
Product description
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.