MAC 5 A4 Resting ECG Analysis System 855001-001 recall (GE Medical Systems China Co., Ltd.)
Medical deviceClass IIOngoing
Summary: GE Medical Systems China Co., Ltd. is recalling MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph. Reason: 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.
What is being recalled
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom. (states named: Florida, Georgia)
How to tell if yours is affected
Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2306-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 21, 2026 |
| Reported | June 10, 2026 |
| Company | GE Medical Systems China Co., Ltd. |
| Company location | Wuxi, China |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 16 |
More recalls from GE Medical Systems China Co., Ltd. · all medical device recalls · recalls from April 2026