Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0151-2008

Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation...

Intuitive Surgical, Inc. / initiated 2007-10-04 / Terminated

Intuitive Surgical, Inc. began a recall of Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0151-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Intuitive Surgical, Inc.
Product
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
Product code
NAY System, Surgical, Computer Controlled Instrument
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
FDA root cause
Mixed-up of materials/components
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.
Quantity in commerce
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, Korea, Russia, and the United Kingdom.
Product codes and lots
SG015, SG053, SG060, SG067, SG096, SG126, SG151, SG164, SG201, SG245, SG267, SG269, SG270, SG271, SG272, SG273, SG275, SG276, SG278, SG280, SG282, SG283, SG285, SG286, SG287, SG288, SG289, SG290, SG291, SG292, SG293, SG294, SG295, SG296, SG297, SG298, SG299, SG300, SG301, SG302, SG303, SG309, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG323, SG324, SG325, SG326, SG329, and SG330