Device recall
Z-1876-2019: ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set…
FDA device recall · Class III · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1876-2019 |
|---|---|
| Recall event | 82937 |
| Product | ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106389-004 ECG Leadwire… |
| Product code | DSA |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 24, 2024 |
| FEI number | 2126677 |
At a glance
- None 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