da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- June 1, 2008
- Posted
- September 16, 2008
- Terminated
- July 29, 2009
- Recall Number
- Z-2204-2008
- Quantity
- 112 systems
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Defective software chip may cause the system to fail and lock up.
Distribution
Worldwide Distribution --- including USA and countries of Belgium, Bulgaria, Canada, China, Denmark, France, Germany, Italy, Korea, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, and United Kingdom.
Lot / Code Info
Serial numbers SG099, SG145, SG162, SG205, SG294, SG295, SG298, SG299, SG300, SG301, SG302, SG303, SG304, SG305, SG306, SG307, SG308, SG309, SG310, SG311, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG320, SG321, SG322, SG323, SG324, SG325, SG326, SG327, SG328, SG329, SG330, SG331, SG332, SG333, SG334, SG35, SG336, SG337, SG39, SG340, SG341, SG342, SG323, SG344, SG345, SG346, SG347, SG348, SG349, SG350, SG351, SG352, SG353, SG355, SG356, SG357, SG358, SG359, SG360, SG361, SG362, SG363, SG364, SG365, SG367, SG368, SG369, SG370, SG371, SG373, SG374, SG375, SG376, SG379, SG380, SG381, SG382, SG383, SG384, SG385, SG386, SG387, SG388, SG390, SG393, SG394, SG395, SG396, SG397, SG399, SG400, SG401, SG402, SG403, SG404, SG405, SG406, SG407, SG408, SG409, SG410, SG411, SG412, and SG413
Root Cause
Software design (manufacturing process)
Action Taken
Recall initiated June 1, 2008. Urgent Device Recall Letters were sent via e-mail, with follow up phone calls and service visits to correct the product. The firm recommended that continued use of the da Vinci S Surgical System during the time period prior to our service update to replace the software chip. The letter emphasizes the importance of always having backup equipment and instrumentation available when performing surgery with the da Vinci S Surgical System and being prepared to convert to alternative surgical techniques, if necessary. Customers are asked to fill out and return the acknowledgement form.