Intuitive Surgical Recalls da Vinci Si Surgeon Side Carts for Testing Compliance
Intuitive Surgical is recalling 30 da Vinci Si Surgeon Side Carts because factory testing may not comply 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. The hazard involves potential non-compliance with UL standards due to a testing error, but the source text explicitly states no injuries or illnesses have been 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 Si Surgeon Side Cart, model number SS3000. The recall was initiated because factory testing on the da Vinci Si Surgical Systems may not be in compliance with UL Standards. The company identified that 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 recall includes specific serial numbers associated with part number 380610-15.
Healthcare facilities and customers should contact Intuitive Surgical for instructions on how to proceed with the recall. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- da Vinci Si Surgeon Side Cart, model number SS3000; 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 non compliance
See all →- ModerateTeva Recalls Methyldopa Tablets Due to Manufacturing Deviations
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