daVinci 5 recallZ-1355-2026 · Intuitive Surgical, Inc. · initiated Dec 30, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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.
FDA root cause category: Process change control
What the company is doing
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].
Recall details
- Recall number
- Z-1355-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 30, 2025
- Posted by the FDA
- Feb 12, 2026
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 47
- Product code
- NAY
- FDA submissions
- K232610
- 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 description
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- daVinci 5 380730Intuitive Surgical, Inc. · System, surgical, computer controlled instrument4 recalls579 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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