FDA DevicesClass II
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis ...
Published: June 10, 2026Recall ID: Z-2306-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Affected Products
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Additional Source Details
| Field | Value |
|---|---|
| City | Wuxi |
| Event id | 98917 |
| Address 1 | No. 19 Changjiang Road |
| Address 2 | Development Zone National Hi-Tech Xin District |
| Code info | Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124 |
| Postal code | N/A |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 16 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260421 |
| Center classification date | 20260603 |
Overview
- Recalling FirmGE Medical Systems China Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.