Recall Z-1355-2026

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Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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: Process change control

Action taken

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 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.