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.
Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
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.
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.
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.
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.
Identify the model number on your power supply (IS3000, IS4200, or IS4000) to determine if it's affected.
Reach out to Intuitive Surgical directly for guidance on next steps if your power supply is listed in the recall.
No, the recall does not require immediate discontinuation. However, affected units may fail during use, so it's important to check the model number and contact Intuitive Surgical for guidance.
The power supply may fail during surgery, which could disrupt the system's operation. This could potentially interrupt minimally invasive procedures.
Check the model number on your power supply. Affected units have model numbers IS3000 (da Vinci Si), IS4200 (da Vinci X), or IS4000 (da Vinci Xi).
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-3254-2018 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-3254-2018 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.
