Device recall
Z-0535-04: Esaote brand Formul@ ECG System; part 9704220000.
FDA device recall · Class II · Esaote Biomedica S.P.A.
Key facts
| Recall number (Z-number) | Z-0535-04 |
|---|---|
| Recall event | 27980 |
| Product | Esaote brand Formul@ ECG System; part 9704220000. |
| Product code | DPS |
| Recalling firm | Esaote Biomedica S.P.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2004 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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