Intuitive Surgical Recalls da Vinci Dual Camera Controllers for Testing Compliance
Intuitive Surgical is recalling 30 da Vinci Dual Camera Controllers because factory testing may not have complied with UL standards due to a malfunctioning test device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 30 units of the da Vinci Dual Camera Controller, model number DC3000. 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 (specifically UT, CA, AZ, CO, FL, HI, MT, NY, TX, and WA) and to one customer in Russia. The specific part number is 372019-01, and the affected serial numbers are 323943, 323895, 323882, 323945, 323994, 323804, 323979, 323987, 324042, and 324086.
The da Vinci Dual Camera Controller is part of the Intuitive Surgical endoscopic Instrument Control System, 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 Dual Camera Controller, model number DC3000; 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
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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Same hazard · testing compliance
See all →- ModerateIntuitive Surgical Recalls da Vinci Instrument Control Boxes
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