Device recall
Z-1951-2011: Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO…
FDA device recall · Class II · Heart Sync, Inc
Key facts
| Recall number (Z-number) | Z-1951-2011 |
|---|---|
| Recall event | 57815 |
| Product | Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. |
| Product code | MLN |
| Recalling firm | Heart Sync, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2011 |
| 510(k) numbers | K080421 |
| FEI number | 1317188 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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