Recall Z-0926-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
| Date | Jul 26, 2019 |
| Status | Terminated |
| Reason | The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system. |
| Root cause | Component design/selection |
| Action | On July 26, 2019, Intuitive sent out a "Urgent Medical Device Correction" letter to affected consignees via FedEx, the Intuitive Customer Portal, and via Email. In addition, to informing their consignees about the recall, the letter also asked consignees to take the following actions: 1. If necessary, please follow the System Troubleshooting section in your specific system user manual for guidance on how to proceed in the scenario where vision loss or a non-recoverable error is experienced, including contacting Intuitive Technical Support. In addition: 2. Forward this letter to your Risk Ma |
| Quantity | 52 surgical systems |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, North Caroli |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171294 | da Vinci X Surgical System Intuitive Surgical, Inc., May 26, 2017 |