Device recall
Z-1487-2012: Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended…
FDA device recall · Class II · Sandhill Scientific, Inc
Key facts
| Recall number (Z-number) | Z-1487-2012 |
|---|---|
| Recall event | 53340 |
| Product | Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders. |
| Product code | FFX |
| Recalling firm | Sandhill Scientific, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2012 |
| 510(k) numbers | K012232 |
| FEI number | 2023374 |
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