[Recalled] da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp end |
|---|---|
| Brand / manufacturer | Intuitive Surgical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2341-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 07 March 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.