Class 2 Device Recall da Vinci SP Surgical System

• Date Initiated by Firm: September 22, 2021
• Create Date: December 27, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0419-2022
• Recall Event ID: 89109
• 510(K)Number: K173906 K182371 K192717 K202968 K211595 K211316
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: 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
• Code Information: All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: Karen Smith; 408-523-2100
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 for your files. 5. Contact Technical Support at the number listed below for assistance if you have experienced this issue: US Technical Support: 800-876-1310, Option 1 (24/7) An Intuitive representative will schedule a site visit to install the next available software update. If you require further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: -US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com."
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical Inc.; 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical, Inc.