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Terminated

Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

FDA Recall Z-0151-2008 · Posted 2008-02-22

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2007-10-04
Date Terminated2011-03-31
Product Quantity63 total units

Reason for Recall

Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that m

Firm Action

A product recall was initiated on October 4, 2007. Direct and Distributor consignees were sent an Important Product Notice, via electronic mail on October 5, 2007. The firm plans on sending a Field Service Engineer to inspect the system and make any necessary corrections.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, LA, MA, MD, MN, NC, NJ, NV, OH, PA, PR, SD, TN, TX, WA, and WI, and countries of Belgium, Ireland, Italy, Korea, Russia, and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063220DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000Intuitive Surgical, Inc. · 2006-12-01K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000Intuitive Surgical, Inc. · 2005-04-29K021036INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000Intuitive Surgical, Inc. · 2002-06-26K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMIntuitive Surgical, Inc. · 2000-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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