Home / Recalls / Intuitive Surgical, Inc. / Z-2630-2017

Z-2630-2017 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
June 1, 2017
Termination Date
October 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

Product Description

da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.

Reason for Recall

da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan

Code Information

Serial Numbers: SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, SK1190

Other recalls by Intuitive Surgical, Inc.

  • Z-2046-2026 Class II — Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical S (April 2, 2026)
  • Z-1855-2026 Class I — Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230 (March 11, 2026)
  • Z-1355-2026 Class II — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Numbe (December 30, 2025)
  • Z-1096-2026 Class II — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2. (December 15, 2025)
  • Z-1697-2026 Class II — Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: (December 9, 2025)
  • Z-1696-2026 Class II — Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: d (December 9, 2025)
  • Z-1700-2026 Class II — Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1701-2026 Class II — Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da V (December 9, 2025)
  • Z-1699-2026 Class II — Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1698-2026 Class II — Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci (December 9, 2025)