Drug recall
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog…
FDA recall event 85540 · Class II · Capso Vision, Inc.
Key facts
| Event ID | 85540 |
|---|---|
| Recall numbers | Z-2536-2020 |
| Recalling firm | Capso Vision, Inc. |
| Product type | Devices |
| Products | The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the… |
| Initiation date | Feb 26, 2020 |
| Report date | Jul 15, 2020 |
| Termination date | Jan 28, 2021 |
| City | Saratoga |
| State | CA |
| Country | United States |
| FEI number | 3008062894 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: