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.
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.
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.
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.
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.
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.
Review the preventative maintenance records for the E-100 Generator to ensure it has been properly maintained.
The E-100 Generator requires regular preventative maintenance to avoid potential malfunction when used with da Vinci Xi and X systems.
Check if your E-100 Generator has been properly maintained and review the preventative maintenance records.
The recall indicates a potential for malfunction if preventative maintenance is not performed, but it does not cause immediate injury or serious harm.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1484-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1484-2022 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
