Z-0816-2018 Class II Terminated

Recalled by Hitachi Medical Systems America Inc — Twinsburg, OH

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
October 20, 2017
Termination Date
April 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55

Product Description

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 Pattern

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.

Code Information

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