Device recall
Z-0104-04: ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal…
FDA device recall · Class III · Sandhill Scientific, Inc
Key facts
| Recall number (Z-number) | Z-0104-04 |
|---|---|
| Recall event | 27519 |
| Product | ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system |
| Product code | FFT |
| Recalling firm | Sandhill Scientific, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 17, 2003 |
| 510(k) numbers | K931963 |
| FEI number | 2023374 |
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