Device recall
Z-2306-2026: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis…
FDA device recall · Class II · GE Medical Systems China Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2306-2026 |
|---|---|
| Recall event | 98917 |
| Product | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph |
| Product code | DXH |
| Recalling firm | GE Medical Systems China Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K221321 |
| FEI number | 3003513129 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database