Intuitive Surgical, Inc.: Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinc

Hazard

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

Details from the source

Reason for recall: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, F Quantity: 2781 Lot/code info: Lot Code: UDI: 00886874114216 FDA Medical Device Listing Number: D531324 See attachment Affected Product List UDI: 00886874114216 FDA Medical Device Listing Number: D295931 See attachment Affected Product List

UPC codes

00886874114216

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.