Medical Device Recall: Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Intuitive Surgical, Inc. · March 13, 2024
Reason for Recall
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
Distribution
US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea
States Affected
AL, CA, CO, FL, KS, KY, MD, MS, NC, NH, NJ, NY, OH, SC, SD, TN, TX, VA, WA, WI, WV
Quantity Affected
53
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1518-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.