Drug recall
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
FDA recall event 85324 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 85324 |
|---|---|
| Recall numbers | Z-2131-2020 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to… |
| Initiation date | Aug 19, 2019 |
| Report date | Jun 3, 2020 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3001675293 |
At a glance
- 1–9 Products in this recall
- 10–99 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: