Intuitive Surgical Recalls da Vinci Patient Carts Due to Fluid Complaints
Intuitive Surgical is recalling 1,754 da Vinci S and SI Patient Carts worldwide due to increased complaints about fluid entering the cart base.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (surgical robot) with a functional defect (fluid entry) that poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,754 Patient Side Carts (PSC) used with the da Vinci S and SI surgical systems. The recall involves models IS2000 and IS 3000. These robotic platforms are the operative components of the da Vinci systems, designed to support instrument and camera arms while working in the sterile field to assist surgeons.
The recall was initiated due to an increased number of complaints regarding fluid entering the patient cart base. The source text does not specify the type of fluid, the cause of the entry, or any reported injuries or illnesses associated with these complaints.
The affected units were distributed worldwide, including the United States (including Puerto Rico) and numerous international markets such as Australia, Canada, China, Germany, Japan, and the United Kingdom. The source text does not provide specific instructions for consumers or healthcare facilities on how to proceed, nor does it list specific lot numbers or serial numbers.
The recalled product
- Product
- Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,754
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)
- Model IS2000 and IS 3000
Distribution
Distributed in 1 state:
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