Intuitive Surgical recalls da Vinci X Surgical System Model IS4200 with defective Arm Controller Joint (ACJ) boards that may fail, potentially causing system malfunctions during surgery.
Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.
Intuitive Surgical is recalling specific da Vinci X Surgical Systems (Model IS4200) that have defective Arm Controller Joint (ACJ) boards. These boards have a high failure rate and could cause system malfunctions during surgical procedures.
The Arm Controller Joint (ACJ) boards in specific da Vinci X Surgical Systems (Model IS4200) have a high failure rate due to a defective component. This could lead to system malfunctions during surgery, potentially affecting the accuracy of instrument control.
Healthcare professionals using the da Vinci X Surgical System Model IS4200 in operating rooms. Surgeons and surgical teams are most at risk if the defective ACJ boards fail during procedures.
Check for system serial numbers (S/N) SL0008 to SL0073 and corresponding ACJ serial numbers listed in the recall notice. The product is used by trained physicians in operating rooms for surgical procedures.
Look for system serial numbers (S/N) SL0008 through SL0073 on the da Vinci X Surgical System.
Confirm if your system has ACJ serial numbers listed in the recall notice (e.g., P117154256, P117154263, etc.).
The da Vinci X Surgical System Model IS4200 with specific system serial numbers (S/N) SL0008 to SL0073 and corresponding ACJ serial numbers.
The Arm Controller Joint (ACJ) boards in these specific systems have a high failure rate due to a defective component, which could cause system malfunctions during surgery.
The recall does not require immediate stop use; however, affected users should check their system serial numbers and ACJ serial numbers to confirm if they are in the recall list.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2341-2018 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2341-2018 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.
