Intuitive Surgical recalls da Vinci Xi surgical systems (IS4000) with high friction in universal surgical manipulators causing resistance, hesitation, and jerking during use. Affected units have specific serial numbers and UDI codes.
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
Intuitive Surgical is recalling da Vinci Xi surgical systems (IS4000) because their universal surgical manipulators have high friction points that cause resistance, hesitation, and jerking during surgery. This could lead to unintended movements that might affect surgical precision.
The universal surgical manipulators (arms) in the da Vinci Xi system have high friction points that cause resistance, hesitation, and jerking when moving. This could lead to unintended movements during surgery, potentially affecting precision and safety.
Surgical teams using the da Vinci Xi system (IS4000) with specific serial numbers are affected. Surgeons and surgical staff are most at risk due to potential unintended movements during procedures.
Check for the da Vinci Xi system (IS4000) with serial numbers including SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, or SL0369. The UDI code 00886874114216 also identifies affected units.
If you experience resistance, hesitation, or jerking when moving the surgical arms, stop using the system immediately.
The da Vinci Xi system (IS4000) with specific serial numbers and UDI code 00886874114216.
Check for the serial numbers SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, or SL0369, or the UDI code 00886874114216.
The recall does not specify a remedy, so contact Intuitive Surgical directly for guidance.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1897-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1897-2020 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.
