RecallDepth

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.

Company
Hitachi Medical Systems America Inc
Recall Initiated
October 20, 2017
Terminated
April 16, 2020
Recall Number
Z-0816-2018
Quantity
55
Firm Location
Twinsburg, OH

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.

Lot / Code Info

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

Root Cause

Mixed-up of materials/components

Action Taken

Hitachi must recall the lot of UST-5550-R Transducers from S/N 1 to S/N 155. If you have a serial number in this range, please contact Hitachi Service at (800) 800-4925 to schedule the recall. Hitachi Sales will contact you regarding the options for a replacement transducer.

More recalls by Hitachi Medical Systems America Inc

View all recalls by this company →