Recall Z-0927-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-0927-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-26

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2019-07-26, terminated 2022-08-10. It names one FDA 510(k) clearance: K173906. Product: da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.. Reason: 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..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-26
Terminated: 2022-08-10
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.·cleared 2018-05-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.