Hitachi Medical Systems America Inc recalls Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation…

Recall date

October 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0816-2018

FDA classification

Class II

Brand / firm

Hitachi Medical Systems America Inc

Sold / distributed

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.

Why it was recalled

The ultrasound probe may not have adequate protection against electrical shock hazards.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.