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

Recall number

Z-0927-2020

Recalling firm

Intuitive Surgical, Inc.

Product

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

Status

Terminated

Initiated

2019-07-26

Posted

not on file

Terminated

2022-08-10

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.

Root cause

Component design/selection

Action

On July 26, 2019, Intuitive sent out a "Urgent Medical Device Correction" letter to affected consignees via FedEx, the Intuitive Customer Portal, and via Email. In addition, to informing their consignees about the recall, the letter also asked consignees to take the following actions: 1. If necessary, please follow the System Troubleshooting section in your specific system user manual for guidance on how to proceed in the scenario where vision loss or a non-recoverable error is experienced, including contacting Intuitive Technical Support. In addition: 2. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures. 3. Inform affected personnel when corrective action has been completed. 4. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 5. In the event the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form. 6. Please retain a copy of this letter and the Acknowledgement Form for your files. 7. An Intuitive representative will contact customers with affected da Vinci Xi, X, and SP Surgical Systems to schedule a site visit and replace the necessary component. 8. If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) " Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 P

Quantity

4 Surgical Systems

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K173906"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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