FDA-Device2026-02-18Class IIPROCESSING DEFECT

Intuitive Surgical da Vinci 5 Surgeon Console display recalled for firmware defect causing vision loss

OTHERNationwide distribution

Contact Intuitive Surgical about da Vinci 5 display firmware

Certain da Vinci 5 Surgeon Console Viewer Displays have outdated firmware that may cause loss of the 3D surgical display or both displays entirely during surgery. When this happens, the surgical instruments remain active even though the surgeon cannot see the surgical field, which could result in unintended tissue contact, bleeding, or injury.

  • If your facility operates a da Vinci 5 with the affected serial numbers (SQ0326–SQ0470 range), contact Intuitive Surgical immediately
  • Do not use the affected console for surgery until the firmware is updated
  • Have Intuitive Surgical perform a firmware update on your display assembly
Hazard

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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

Sold states
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.
Affected count
47
Manufactured in
1266 Kifer Rd, N/A, Sunnyvale, CA, United States
Products
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2026

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