Z-0927-2020 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
February 12, 2020
Initiation Date
July 26, 2019
Termination Date
August 10, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 Surgical Systems

Product Description

da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.

Reason for Recall

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wisconsin and countries of Belgium, Brazil, France, Germany, India, Ireland, Italy, Japan, Norway, Panama, Poland, South Korea, Spain, Taiwan, and United Kingdom

Code Information

System Serial # PSC Serial # VSC Serial # SP0047 Not Affected 675054 SP0049 Not Affected 674261 SP0050 Not Affected 675051 SP0054 Not Affected 682482