Drug recall
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
FDA recall event 89641 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 89641 |
|---|---|
| Recall numbers | Z-1209-2022, Z-1210-2022 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440, VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. |
| Initiation date | Mar 3, 2022 |
| Report date | Jun 8, 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: