Recall Z-0419-2022 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A
| Date | Sep 22, 2021 |
| Status | Open, Classified |
| Reason | Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot. |
| Root cause | Software design |
| Action | On 09/22/2021, the firm notified affected customers via mail of "Urgent Medical Device Correction - ISIFA2021-04-C." The letter indicated, "As part of the field action process, please complete the actions below: 1. Ensure that all personnel who use the da Vinci SP System read and understand the contents of this letter. 2. Inform the personnel when the software update has been completed by the Intuitive representative. 3. Complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form |
| Quantity | 46 |
| Distribution | US Nationwide distribution in the states of Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc., May 31, 2018 |
| K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc., Mar 14, 2019 |
| K192717 | da Vinci SP Surgical System Intuitive Surgical, Inc., Sep 28, 2020 |
| K202968 | Da Vinci SP Surgical System Intuitive Surgical, Inc., Dec 22, 2020 |
| K211316 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc., Jul 23, 2021 |
| K211595 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc., Jun 23, 2021 |