The Recall Desk
SevereFDA (Devices)·Z-0927-2020·Announced 2020-02-12

Intuitive Surgical Recalls da Vinci SP Systems Due to Defective Capacitors

Intuitive Surgical is recalling four da Vinci SP Surgical Systems because defective capacitors on circuit boards may cause vision loss or non-recoverable 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 prevent the use of the system during surgical procedures, meeting the criteria for a Severe rating.

Plain-English summary

Intuitive Surgical, Inc. is recalling four da Vinci SP Surgical Systems (model SP1098) 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 systems distributed worldwide, including nationwide distribution in the United States and in specific countries such as 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 Serial Number, PSC Serial Number, and VSC Serial Number against the provided list. The source text indicates that specific serial numbers SP0047, SP0049, SP0050, and SP0054 are listed as 'Not Affected' in the provided code information, but the recall notice generally addresses potentially defective units on VSC and/or PSC components. Users should contact Intuitive Surgical for further instructions on managing the defect.

The recalled product

Product
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robotics
Hazard
Affected units
4

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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