Intuitive Surgical E-100 Generator Recall: Preventative Maintenance Not Performed
Intuitive Surgical recalls E-100 Generators (PN 374848-09) due to preventative maintenance not being performed, which could lead to malfunction when used with da Vinci Xi and X systems.
Lower-risk recall
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling E-100 Generators (model 374848-09) that are used with da Vinci Xi and X surgical robots. The recall is because these devices require regular preventative maintenance to avoid potential malfunction. Read more at govinfonow.com/recall/60464-intuitive-surgical-e-100-generator-recall-preventative-maintenance-not-performed.
Source Summary by GovInfoNow · govinfonow.com/recall/60464-intuitive-surgical-e-100-generator-recall-preventative-maintenance-not-performed · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1484-2022
Cite this page
“Intuitive Surgical E-100 Generator Recall: Preventative Maintenance Not Performed.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60464-intuitive-surgical-e-100-generator-recall-preventative-maintenance-not-performed. Based on FDA recall #Z-1484-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1484-2022%22&limit=1).
Why it’s dangerous
The E-100 Generator is a bipolar electrosurgical unit that requires regular preventative maintenance. If maintenance isn't performed, it could malfunction when used with da Vinci Xi and X surgical robots, but this does not cause immediate harm.
Who’s affected
Surgical teams using the E-100 Generator with da Vinci Xi and X systems. The risk is low as the hazard is related to preventative maintenance not being done, not immediate failure.
How to tell if you have this one
The E-100 Generator (model 374848-09) is used with da Vinci Xi and X systems. Check the product label for the model number and system serial numbers listed in the recall notice.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Maintenance Records
Review the preventative maintenance records for the E-100 Generator to ensure it has been properly maintained.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 45 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1484-2022 (June 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1484-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.