Drug recall
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient…
FDA recall event 90826 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 90826 |
|---|---|
| Recall numbers | Z-0133-2023 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected… |
| Initiation date | Sep 20, 2022 |
| Report date | Nov 2, 2022 |
| 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: