FDA-Device2024-04-17Class II
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Intuitive Surgical, Inc.
Hazard
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.
Sold states
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
Affected count
53
Manufactured in
1266 Kifer Rd, N/A, Sunnyvale, CA, United States
Products
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2024Don't want to check this manually?
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