Z-1428-2026Class II

Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery

Name: Z-1428-2026 Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery
Creator: Intuitive Surgical, Inc.
Published: 2025-11-17
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2025-11-17 / Open, Classified / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery on 2025-11-17. FDA classified it as Class II and gives the reason as "An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor". 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-1428-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-17
Posted: 2026-02-18
Recalling firm: Intuitive Surgical, Inc.
Product: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 11/17/2025, the firm emailed a "New Customer Communication" to customers informing them that Intuitive has become aware, following the distribution of P1.2.1 software version for dV5 Systems between October 17, 2025 and October 24, 2025, of an increase in 48306 error events observed on Da Vinci 5 Surgical Systems in dual console configuration, causing User Interface (UI) application crashes and loss of interaction at the affected node. Customers are instructed to: Continue Safe Use: If error 48306 occurs, follow the on-screen instructions and select Retry to recover. Affected systems may continue to be used following the recovery of error 48306 with the awareness of potential loss of non-essential UI features as outlined below: " User interface may not be displayed on connected external monitor live endoscopic video is still displayed " User interface may not be displayed on the dV5 Tower monitor - live endoscopic video is still displayed " System may be unable to activate Tile/Overlay layout user is unable to stream video input from external sources into the Console viewer. If UI streaming remains unavailable, restart the system during the procedure to restore full functionality. Guidance is available in Appendix B, Faults that Require Restarting , of Da Vinci 5 User Manual PN 555500-05. Intuitive Surgical is developing a corrective software patch (version P1.2.2). When ready, customers will be contacted to schedule installation. Please take the additional following actions: 1. Display this communication with systems; ensure it is in a place likely to be seen/viewed by operators. 2. Retain a copy of this letter and the acknowledgement form for your files. For questions - contact Intuitive Representative or contact Intuitive Customer Service at: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected].
Quantity in commerce: 12
Distribution: US distribution: LA, MA, NY, PA, TX, and VA.
Product codes and lots: UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1428-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1428-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-18

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)