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Use caution Medical device recall · FDA · Published March 7, 2018

Intuitive Surgical da Vinci X System Model IS4200: Defective Arm Controller Joint Boards

Intuitive Surgical recalls da Vinci X Surgical System Model IS4200 with defective Arm Controller Joint (ACJ) boards that may fail, potentially causing system malfunctions during surgery.

🇺🇸 FDA recall #Z-2341-2018Medical 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 specific da Vinci X Surgical Systems (Model IS4200) that have defective Arm Controller Joint (ACJ) boards. These boards have a high failure rate and could cause system malfunctions during surgical procedures. Read more at govinfonow.com/recall/71750-intuitive-surgical-da-vinci-x-system-model-is4200-defective-arm.

Source Summary by GovInfoNow · govinfonow.com/recall/71750-intuitive-surgical-da-vinci-x-system-model-is4200-defective-arm · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2341-2018

Cite this page

“Intuitive Surgical da Vinci X System Model IS4200: Defective Arm Controller Joint Boards.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71750-intuitive-surgical-da-vinci-x-system-model-is4200-defective-arm. Based on FDA recall #Z-2341-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2341-2018%22&limit=1).

Why it’s dangerous

The Arm Controller Joint (ACJ) boards in specific da Vinci X Surgical Systems (Model IS4200) have a high failure rate due to a defective component. This could lead to system malfunctions during surgery, potentially affecting the accuracy of instrument control.

Who’s affected

Healthcare professionals using the da Vinci X Surgical System Model IS4200 in operating rooms. Surgeons and surgical teams are most at risk if the defective ACJ boards fail during procedures.

How to tell if you have this one

Check for system serial numbers (S/N) SL0008 to SL0073 and corresponding ACJ serial numbers listed in the recall notice. The product is used by trained physicians in operating rooms for surgical procedures.

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

What to do — step by step

  1. Check System Serial Number

    Look for system serial numbers (S/N) SL0008 through SL0073 on the da Vinci X Surgical System.

  2. Verify ACJ Serial Numbers

    Confirm if your system has ACJ serial numbers listed in the recall notice (e.g., P117154256, P117154263, etc.).

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide AR, CA, FL, GA, IL, IA, MN, MS, NE, OK, TN, and TX. Foreign distribution was made to Australia, Austria, Finland, France, Germany, Italy, Netherlands, Spain, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Florida, Georgia, Illinois, Iowa, Minnesota, Mississippi, Nebraska, Oklahoma, Tennessee, Texas.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Mar 7, 201812. FDA classified it Class II: Jul 2, 201823. Published in FDA’s Enforcement Report: Jul 11, 201834. FDA terminated the recall: Jul 29, 2020420182020
  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.

✎ GovInfoNow

Questions people ask

Do I need to stop using this system immediately?

The recall does not require immediate stop use; however, affected users should check their system serial numbers and ACJ serial numbers to confirm if they are in the recall list.

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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-2341-2018 (March 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2341-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 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