FDA-Device2018-03-07Class II
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
Hitachi Medical Systems America Inc
Hazard
The ultrasound probe may not have adequate protection against electrical shock hazards.
Sold states
Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.
Affected count
55
Manufactured in
1959 Summit Commerce Park, N/A, Twinsburg, OH, United States
Products
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0816-2018Don't want to check this manually?
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