Recall Z-1960-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Xi Surgical System
| Date | Nov 21, 2018 |
| Status | Terminated |
| Reason | Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery. |
| Root cause | Process control |
| Action | On 11/21/2018, the firm sent an "Urgent Medical Device Correction" Notification to its customers informing them that the firm had become aware of specific surgical systems were shipped with a manufacturing variation in the arm, which may result in a persistent recoverable fault (error 23087) with could occur prior or during a surgical procedure. The firm emphasized that as indicated in the User Manual, if this fault is persistent, ten the affected arm may be disabled. The firm is instructing that: 1. Inform surgeons and patient side assistants using the surgical system to read and understand |
| Quantity | 74 USMs containing affected rotors. |
| Distribution | U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |