Intuitive Surgical Recalls da Vinci Si Vision System Carts
Intuitive Surgical is recalling 30 da Vinci Si Vision System Carts because factory testing may not have complied with UL standards due to a malfunctioning test device.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential non-compliance with UL standards due to a testing error, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 30 da Vinci Si Vision System Carts, model number VS3000. The recall is being conducted because factory testing on the da Vinci Si Surgical Systems may not have been in compliance with UL Standards. This issue arose because one of the testing devices used during the manufacturing process was found to be working incorrectly.
The affected units were distributed worldwide, including in the United States (specifically Utah, California, Arizona, Colorado, Florida, Hawaii, Montana, New York, Texas, and Washington) and to one customer in Russia. The recall involves specific serial numbers associated with part number 380990-11.
Intuitive Surgical is the recalling firm. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it report any injuries or illnesses associated with this recall.
The recalled product
- Product
- da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended f
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 30
Distribution
Part of a larger recall action
This product is one of 4 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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