Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transforme

FDA device recall Z-0152-2008 · posted 2008-02-22 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

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

Action taken

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

Status

Terminated

Product code

NAY

Quantity affected

63 total units

Distribution

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,

Date initiated

2007-10-04

Date posted

2008-02-22

Date terminated

2011-03-31

Location

Sunnyvale, CA

Related 510(k) clearances