The Recall Desk
SevereFDA (Devices)·Z-0926-2020·Announced 2020-02-12

Intuitive Surgical Recalls da Vinci Systems Due to Defective Capacitors

Intuitive Surgical is recalling 52 da Vinci X surgical systems worldwide due to defective capacitors that may cause vision loss or system errors.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can cause vision loss or system failure during surgical procedures, meeting the criteria for a Severe rating.

Plain-English summary

Intuitive Surgical, Inc. is recalling 52 da Vinci X Surgical Systems (IS4200) due to potentially defective capacitors on circuit boards installed on certain Vision Side Carts (VSC) and/or Patient Side Carts (PSC). The affected systems are used with endoscopes, surgical instruments, and accessories to perform minimally invasive surgical procedures.

The defect may result in vision loss or non-recoverable errors 307 or 319, which prevent further use of the system. The recall covers distribution in the United States and several international countries, including Belgium, Brazil, France, Germany, India, Ireland, Italy, Japan, Norway, Panama, Poland, South Korea, Spain, Taiwan, and the United Kingdom.

Healthcare facilities should identify affected units by checking the System, PSC, and VSC serial numbers against the provided list. Intuitive Surgical is the recalling firm responsible for addressing the defect.

The recalled product

Product
da Vinci X Surgical System Surgical System, IS4200, 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
Hazard
Affected units
52

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

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.

See all 3 products in this recall →

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