da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Enforcement
- Recall Number
- Z-0927-2020
- Event ID
- 84335
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Intuitive Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 12, 2020
- Initiation Date
- July 26, 2019
- Classification Date
- January 31, 2020
- Termination Date
- August 10, 2022
- Address
- 1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, 94086-5304, United States
Description
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
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.
System Serial # PSC Serial # VSC Serial # SP0047 Not Affected 675054 SP0049 Not Affected 674261 SP0050 Not Affected 675051 SP0054 Not Affected 682482
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
4 Surgical Systems