Amy J. Reed Collaborative Petitions FDA for Class I Recall of da Vinci 5 Robotic Surgical Systems

Professors David Simon and Hooman Noorchashm, co-directors of AJRC, have filed a petition with the FDA requesting that the Commissioner of Food and Drugs immediately request Intuitive Surgical issue a Class I recall of all model 5 da Vinci Surgical Systems.

    Amy J. Reed Collaborative Petitions FDA for Class I Recall of da Vinci 5 Robotic Surgical Systems

    02.04.26 — Northeastern Law professors David A. Simon and Hooman Noorchashm, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC), have filed a petition with the U.S. Food and Drug Administration (FDA) requesting that the Commissioner of Food and Drugs immediately request Intuitive Surgical issue a Class I recall of all model 5 da Vinci Surgical Systems due to a serious intraoperative power failure defect causing prolonged reboot delay, loss of visualization and control, and potential insufflation loss in da Vinci 5 models, publish an urgent medical device safety communication, and send a warning letter to Intuitive Surgical.

    “Intuitive Surgical’s da Vinci systems hold a virtual monopoly over the robotic surgery industry across the US and worldwide. However, the unmitigated intrinsic power loss defect in Intuitive’s flagship da Vinci devices, which the manufacturer has acknowledged, poses a risk of severe injury or death to unsuspecting/uninformed patients — and a risk to healthcare providers and Intuitive’s investors,” said Noorchashm, an internationally recognized medical device safety expert.

    “Public communication about device risks is crucial to public health, safety and trust. We urge the FDA to act swiftly to ensure no patient, surgeon or healthcare facility is put at risk unnecessarily,” said Simon, a healthcare law expert.

    The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability.

    >> View the FDA Docket Submission

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