Z-0927-2020Class II

da Vinci SP Surgical System, SP1098, 00886874114605

Name: Z-0927-2020 da Vinci SP Surgical System, SP1098, 00886874114605
Creator: Intuitive Surgical, Inc.
Published: 2019-07-26
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2019-07-26 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive... on 2019-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0927-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-26
Posted: 2020-01-31
Terminated: 2022-08-10
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.
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: design
FDA 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: [email protected]. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] " 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 in commerce: 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
Product codes and lots: System Serial # PSC Serial # VSC Serial # SP0047 Not Affected 675054 SP0049 Not Affected 674261 SP0050 Not Affected 675051 SP0054 Not Affected 682482

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0927-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0925-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-01-31
Z-0926-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-01-31
Z-0927-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-01-31

Product code NAY

K173906Class IIda Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. / cleared 2018-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)