Intuitive Surgical Recalls da Vinci Xi Systems Due to Defective Capacitors
Intuitive Surgical is recalling 123 da Vinci Xi surgical systems worldwide due to potentially defective capacitors that may cause vision loss or system errors.
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 medical device with a defect that can cause vision loss or system failure during surgery. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, corresponding to a score of 3.
Plain-English summary
Intuitive Surgical, Inc. is recalling 123 da Vinci Xi Surgical Systems (IS4000) distributed worldwide, including in the United States and various international markets. The recall is due to potentially defective capacitors on circuit boards installed on certain Vision Side Carts (VSC) and/or Patient Side Carts (PSC).
The defect may result in vision loss or non-recoverable errors 307 or 319, which prevent further use of the system. The affected units are identified by specific System, Patient Side Cart, and Vision Side Cart serial numbers listed in the recall documentation.
Healthcare facilities and users should check their equipment serial numbers against the provided list to determine if their systems are affected. Intuitive Surgical is the recalling firm responsible for addressing the defect.
The recalled product
- Product
- da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Affected units
- 123
Distribution
Part of a larger recall action
This product is one of 3 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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