FDA recall Z-0816-2018

Product

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.

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2017-10-20

Report date

2018-03-07

Termination date

2020-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Twinsburg, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0816-2018