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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

da Vinci 5 Surgeon Console Viewer Display Recalled for Firmware Issue

Agency Publication Date: February 12, 2026
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Summary

Intuitive Surgical, Inc. is recalling 47 units of the da Vinci 5 Surgeon Console Viewer Display due to outdated firmware. This software error can cause the sudden loss of one or both viewer displays during robotic surgery, potentially leading to a loss of depth perception or a complete loss of vision for the surgeon while instruments remain active. If this occurs, surgeons may need to switch to a different surgical method to safely complete the procedure.

Risk

The outdated firmware can cause the display to fail without warning, which may result in surgical instruments making unintended contact with patient tissue, causing injury or bleeding. While the surgeon's view is lost, the robotic instruments remain active, increasing the risk of surgical complications.

What You Should Do

  1. Identify if your surgical system is affected by checking the Unique Device Identifier (UDI) 00886874119747 and the specific serial number on the device label.
  2. Check the serial number on your Surgeon Console Viewer Display against the following list: 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, or SQ0761.
  3. Stop using the recalled device immediately to prevent surgical visualization failure.
  4. Contact Intuitive Surgical, Inc. or your authorized distributor to arrange for a firmware update, repair, or replacement of the affected display assembly.
  5. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000
Model / REF:
380730-45
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
UDI:
00886874119747

Firmware is outdated resulting in potential loss of 3D or 2D surgical field visualization.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98205
Status: Active
Manufacturer: Intuitive Surgical, Inc.
Sold By: Authorized medical device distributors; Directly to hospitals and surgical centers
Manufactured In: United States
Units Affected: 47
Distributed To: Kansas, Arizona, Massachusetts, Florida, Michigan, North Carolina, Illinois, District of Columbia, Texas, Kentucky, Mississippi, California, Minnesota, Nevada, New York, Wisconsin, Idaho, Georgia, Connecticut, South Carolina, Utah, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.