Intuitive Surgical Recalls da Vinci Instrument Control Boxes
Intuitive Surgical is recalling 30 da Vinci Instrument Control Boxes because factory testing may not have met 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, but the source text describes a compliance issue with factory testing standards rather than a direct defect causing injury or illness. No injuries or illnesses are reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Intuitive Surgical, Inc. is recalling 30 units of the da Vinci Instrument Control Box, model number ICB3000. The recall is limited to specific serial numbers 323986 and 324198, associated with part number 372012-96.
The recall was initiated because factory testing on 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 devices were distributed worldwide, including in the United States (UT, CA, AZ, CO, FL, HI, MT, NY, TX, and WA) and to one customer in Russia.
The da Vinci Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments for adult and pediatric use. Users should contact Intuitive Surgical for further instructions regarding the recall.
The recalled product
- Product
- da Vinci Instrument Control Box, model number ICB3000; 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
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part number 372012-96: Serial numbers: 323986 324198.
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.
See all 4 products in this recall →Related recalls
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