Z-0964-2026Class II

da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

Name: Z-0964-2026 da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Creator: Intuitive Surgical, Inc.
Published: 2024-08-21
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2024-08-21 / Open, Classified / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 on 2024-08-21. FDA classified it as Class II and gives the reason as "Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0964-2026
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-21
Posted: 2025-12-19
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
Root cause tag: design
FDA root cause: Device Design
Action: On 8/21/2024, correction notices were sent to customers who were informed of the following: 1) Share this notification with all personnel at your site who perform and support da Vinci procedures. 2) Inform affected personnel when the correction has been completed. 3) Complete and return the acknowledgement form via email to [email protected] 4) Retain a copy of this letter and the acknowledgement form for your files. 5) Firm is actively working on making updated motor module assemblies available. Once available, an Intuitive representative will schedule a visit to replace the affected motor module sub-assembly. If you need further information or support concerning this notification, please contact the firm's Customer Service: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]
Quantity in commerce: 144
Distribution: US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.
Product codes and lots: UDI-DI: 00886874119747. Serial Numbers: 10476314, 10485693, 10496049, 10497992, 10503432, 10503433, 10507302, 10509551, 10511044, 10511047, 10516467, 10518960, 10518961, 10522438, 10522439, 10522441, 10523771, 10523773, 10523775, 10523776, 10523777, 10523778, 10523779, 10523780, 10523781, 10529917, 10529918, 10529919, 10529920, 10529922, 10534426, 10534428, 10534429, 10534430, 10534752, 10534753, 10534754, 10534755, 10534757, 10543027, 10543028, 10543048, 10543051, 10544670, 10544676, 10544677, 10544678, 10547713, 10547717, 10547724, 10547728, 10551553, 10551554, 10552616, 10552618, 10552620, 10552621, 10556681, 10556682, 10558195, 10558197, 10558198, 10558202, 10560603, 10560604, 10560607, 10562584, 10562585, 10562586, 10562588, 10565609, 10565610, 10565614, 10567141, 10567143, 10567145, 10569365, 10569367, 10569368, 10569369, 10570704, 10570705, 10570706, 10570707, 10573677, 10573678, 10573679, 10573680, 10573681, 10573682, 10573683, 10573684, 10573685, 10573686, 10576019, 10576021, 10576022, 10576023, 10576024, 10576025, 10576026, 10576027, 10576028, 10579442, 10579446, 10579453, 10579455, 10579456, 10579457, 10579461, 10579466, 10582427, 10582428, 10582429, 10591177, 10591179, 10591180, 10591184, 10591197, 10594614, 10594615, 10594616, 10594617, 10594618, 10594619, 10597107, 10597108, 10597109, 10597110, 10599042, 10599044, 10599045, 10599048, 10600750, 10600753, 10603334, 10603335, 10603343, 10603344, 10603345, 10603367, 10605468, 10606129, 10606133

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0964-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0964-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-19

Product code NAY

K232610Class IIda Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationIntuitive Surgical, Inc. / cleared 2024-03-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)