Z-1355-2026Class II

da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45

Name: Z-1355-2026 da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Creator: Intuitive Surgical, Inc.
Published: 2025-12-30
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2025-12-30 / Open, Classified / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 on 2025-12-30. FDA classified it as Class II and gives the reason as "Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both...". 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-1355-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-30
Posted: 2026-02-12
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
Root cause tag: software
FDA root cause: Process change control
Action: On 12/30/2025, correction notices were mailed and emailed to customers who were informed the following: If single-viewer failure occurs during a procedure, when clinically safe to do so, restart the system to restore 3D visualization in the viewer. If dual-viewer failure occurs during a procedure, be aware that instrument motion will not be automatically halted by the system. Instrument motion can be halted by removing the surgeon s head from the viewer. The surgeon maintains the ability to control the instruments while their head is in the viewer. To ensure instruments do not cause unintended tissue interaction, the bedside user should maneuver installed instruments into a safe space in the surgical field, using an external monitor for visualization. Once the instruments are safely positioned, restart the system to restore visualization. At any point during the sequence, the surgeon may press E Stop to put the system in a safe state (arms locked, no instrument motion). If any viewer display issue is detected, the user should avoid starting any additional procedures with the affected system until firm has repaired the system. Forward this notification to all personnel at your site who perform and support these procedures. Complete and return the acknowledgement form via email to [email protected] Retain a copy of this letter and the acknowledgement form for your files. Firm's Field Engineers will contact affected customers to schedule a site visit to upgrade the Viewer Display firmware on affected systems. If you need further information or support concerning this Urgent Medical Device Correction, please contact your Clinical Sales Representative or contact the firm's Customer Service at: North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected].
Quantity in commerce: 47
Distribution: US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA.
Product codes and lots: UDI: 00886874119747, Serial: SQ0326, SQ0336, SQ0341, SQ0345, SQ0346, SQ0356, SQ0367, SQ0368, SQ0375, SQ0377, SQ0379, SQ0380, SQ0386, SQ0387, SQ0389, SQ0394, SQ0395, SQ0398, SQ0401, SQ0404, SQ0412, SQ0413, SQ0415, SQ0419, SQ0420, SQ0422, SQ0425, SQ0427, SQ0428, SQ0432, SQ0433, SQ0436, SQ0443, SQ0447, SQ0448, SQ0451, SQ0454, SQ0457, SQ0458, SQ0462, SQ0464, SQ0469, SQ0470, SQ0662, SQ0727, SQ0740, SQ0761

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1355-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1355-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-12

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)