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Use caution Medical device recall · FDA · Published July 16, 2018

Intuitive Surgical da Vinci Si/X/Xi Surgical System Power Supply Recall: Risk of Failure

Intuitive Surgical recalls specific Redundant Medical Grade Power Supply (RMGPS) units for da Vinci Si/X/Xi Surgical Systems due to potential failure during use, which could disrupt surgery. Affected units have model numbers listed in the recall notice.

🇺🇸 FDA recall #Z-3254-2018Medical deviceIntuitive Surgical ›
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Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd Bldg 101 · Sunnyvale, CA 94086-5304
✎ GovInfoNow plain-language explainer

What happened, in plain English

Intuitive Surgical is recalling certain Redundant Medical Grade Power Supply (RMGPS) units for da Vinci Si, X, and Xi surgical systems. These units may fail during use, potentially disrupting surgery if not properly maintained. Read more at govinfonow.com/recall/70581-intuitive-surgical-da-vinci-si-x-xi-surgical-system-power.

Source Summary by GovInfoNow · govinfonow.com/recall/70581-intuitive-surgical-da-vinci-si-x-xi-surgical-system-power · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3254-2018

Cite this page

“Intuitive Surgical da Vinci Si/X/Xi Surgical System Power Supply Recall: Risk of Failure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70581-intuitive-surgical-da-vinci-si-x-xi-surgical-system-power. Based on FDA recall #Z-3254-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3254-2018%22&limit=1).

Why it’s dangerous

The recalled power supplies were manufactured incorrectly and may fail before or during surgery. This could disrupt the system's operation, potentially causing interruptions in minimally invasive procedures.

Who’s affected

Surgical teams using da Vinci Si, X, or Xi systems with the recalled power supplies. Surgeons and medical staff are most at risk if the power supply fails during critical procedures.

How to tell if you have this one

Check for the model numbers listed in the recall notice: IS3000 for da Vinci Si, IS4200 for da Vinci X, and IS4000 for da Vinci Xi systems. The units are part of the Surgeon Console and Patient Side Carts.

  • Brand
    Intuitive Surgical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Power Supply Model

    Identify the model number on your power supply (IS3000, IS4200, or IS4000) to determine if it's affected.

  2. Contact Manufacturer

    Reach out to Intuitive Surgical directly for guidance on next steps if your power supply is listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 5.2 years after the firm started it.

1. Firm started the recall: Jul 16, 201812. FDA classified it Class II: Sep 26, 201823. Published in FDA’s Enforcement Report: Oct 3, 201834. FDA terminated the recall: Oct 5, 2023420182023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3254-2018 (July 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3254-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA