Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation...
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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
