Asensus Surgical recalls Senhance Surgical System with software version 2.7.4 due to uncontrolled arm motion after surgeon disengages teleoperation. Affected units may require repair or update to prevent unintended movement during surgery.
Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.
Asensus Surgical is recalling the Senhance Surgical System with software version 2.7.4 because it can move uncontrollably after the surgeon disengages teleoperation. This could lead to unintended surgical movements if the system malfunctions during procedures.
The system may rotate continuously in one direction after the surgeon removes teleoperation engagement. This uncontrolled motion could cause unintended surgical movements if the system malfunctions during procedures.
Surgical teams using the Senhance Surgical System with software version 2.7.4 are most at risk. The recall affects specific units with serial numbers listed in the official notice.
Check for the Senhance Surgical System with software version 2.7.4. Affected units have specific serial numbers listed in the recall notice, including SN 00012, SN 00016, and others.
Verify the software version on your Senhance Surgical System; affected units have version 2.7.4.
Reach out to Asensus Surgical for guidance on next steps if your unit is affected.
The recall identifies a potential for uncontrolled arm motion after disengaging teleoperation, which could cause unintended surgical movements. However, no injuries have been reported.
Check for the specific serial numbers listed in the recall notice, including SN 00012, SN 00016, and others, with software version 2.7.4.
Contact Asensus Surgical directly for instructions on next steps, as the recall does not specify a repair or update timeline.
We’ve drafted a message you can send Asensus Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0170-2024 — Asensus Surgical Asensus Surgical Hello, I own a Asensus Surgical that is covered by recall Z-0170-2024 from Asensus 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.
