Intuitive Surgical recalls da Vinci X surgical systems with a potential error 230:87 causing arm dysfunction during surgery. Affected units have specific model and UDI numbers.
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Intuitive Surgical is recalling da Vinci X surgical systems that may cause arm functionality issues during surgery due to a manufacturing variation. This could lead to persistent errors affecting surgical procedures.
A manufacturing variation in the robotic arm can cause a persistent error (23087) that may lead to loss of arm functionality. This could disrupt surgery by preventing the robotic arm from operating correctly.
Surgical teams using the da Vinci X system with the specific model and UDI numbers listed are affected. Surgeons and surgical staff are at highest risk during procedures.
Check for the model number IS4200 and UDI number 00886874114216 on the device. The da Vinci X system was sold with these specific identifiers.
Identify the model number (IS4200) and UDI (00886874114216) on the device to confirm if it's affected.
The recall addresses a potential error that could cause loss of arm functionality during surgery, but the risk level is not severe enough to require immediate stop use.
Check for the model number IS4200 and UDI number 00886874114216 on the device. Affected units have these specific identifiers.
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-1961-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1961-2020 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.
