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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

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 Class 2 Device Recall da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuationsee related information
Date Initiated by FirmDecember 30, 2025
Date PostedFebruary 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1355-2026
Recall Event ID 98205
510(K)NumberK232610 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Productda Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Code Information 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
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information ContactShahbaz Khan
408-523-2443
Manufacturer 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for Recall		Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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.
FDA Determined
Cause 2		Process change control
ActionOn 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 Recalls@intusurg.com 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: customerservice@intusurg.com.
Quantity in Commerce47
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NAY
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