Z-0133-2023Class II

da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC)...

Name: Z-0133-2023 da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC)...
Creator: Intuitive Surgical, Inc.
Published: 2022-09-20
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2022-09-20 / Open, Classified / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS) on 2022-09-20. FDA classified it as Class II and gives the reason as "Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0133-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-20
Posted: 2022-10-25
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
Root cause tag: software
FDA root cause: Software Design Change
Action: On 09/20/22, correction notices were mailed to customers. Customers were advised of the following: 1) The system software version can be located on the Vision Cart Touchscreen in the Troubleshooting Tab. 2) Ensure all device users read and understand this notice. 3) Notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4) Ensure proper instrument connections to the generator(s) and continue to follow all existing warnings and cautions found in user manuals 551400-15, USER MANUAL,SYS,P10,US,IS4000, 553873-07, USER MANUAL,I-A,MDR P10,IS4000-IS4200 and 554070-04, ADD,I-A,FORCE BIPOLAR,IS4000,IS4200. 5) Complete and return the acknowledgement form. 6) The recalling firm will follow-up with customers and schedule a software upgrade. 7) After the upgrade, inform all personnel that the software update/upgrade was completed. 8) If you have experienced this issue or require additional assistance, contact Technical Support: 800-876-1310, Option 1 (24/7) or [email protected]
Quantity in commerce: 162
Distribution: US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC
Product codes and lots: Software version P10 (OS4 v10.0.0/A70_P10_B738) SOFTWARE,EMBEDDED RLS,IS4000 AND IS4200,A70_P10_B738 (Model: 610092-738) on Model Name/Model Number/UDI-DI: ASSY,PSCART,IS4000,4-ARM,P10/380652-55/00886874110720, ASSY,SSC,IS4000,P10/380677-28/00886874110744, ASSY,VSS VISION SYSTEM,IS4000,P10/381121-45/00886874110898, ASSY,PSCART,IS4200,P10/380620-47/00886874115404, ASSY,VSC,IS4000,RECONDITIONED,P10/380721-15/00886874115343, ASSY,SSC,IS4000,RECONDITIONED,P10/380723-16/00886874115374

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0133-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-25

Product code NAY

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)