Hitachi Medical Systems America Inc: Medical Device Recall in 2018 - (Recall #: Z-0816-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 20, 2017

Date Posted: March 7, 2018

Recall Number: Z-0816-2018

Event ID: 79160

Reason for Recall:

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

Status: Terminated

Product Quantity: 55

Code Information:

17 21 32 37 38 39 41 43 45 46 48 57 58 59 61 63 64 69 73 77 78 81 82 86 87 92 96 97 99 107 108 109 114 115 116 118 120 121 122 126 129 130 132 135 139 140 141 143 144 147 148 151 155

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.

Voluntary or Mandated:

Voluntary: Firm initiated