Intuitive Surgical Recalls da Vinci 5 Surgeon Console Viewer Displays Over Visualization Risks

What Happened

Intuitive Surgical, Inc. has initiated a voluntary recall of specific da Vinci 5 Surgeon Console Viewer Displays due to the inclusion of outdated firmware. This technical defect can lead to the loss of one display, resulting in a loss of 3D depth perception while maintaining 2D visualization, or the loss of both displays, leading to a complete loss of visualization. Because the surgical instruments remain active even if the display fails, this malfunction could lead to unintended instrument contact with tissue, potentially resulting in patient injury or bleeding. In such events, an alternate surgical modality may be required.

Which Products Are Affected

The recall affects 47 units of the da Vinci 5 Surgeon Console Viewer Display (ASSY, DV5 CONSOLE, IS5000).

• Part Number: 380730-45
• UDI: 00886874119747
• Recall Number: Z-1355-2026
• Serial Numbers: 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.

Geographic Scope: Affected units were distributed in the following U.S. states and districts: KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, and VA.

What You Should Do

Medical facilities and surgical centers utilizing the da Vinci 5 system should check their console serial numbers against the affected list provided. As this is a firm-initiated voluntary recall, users should follow all instructions provided by Intuitive Surgical, Inc. regarding firmware updates or equipment servicing. For further information, the recalling firm is located at 1266 Kifer Rd, Sunnyvale, CA 94086-5304.

Why This Matters

A loss of visualization during robotic-assisted surgery while instruments remain active poses a significant risk of internal injury or bleeding, potentially necessitating an immediate change in surgical approach.

Source

FDA Recall Notice - Recall Number Z-1355-2026, Intuitive Surgical, Inc.