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.
This recall has been terminated (originally issued October 20, 2017).
- Recall Initiated
- October 20, 2017
- Terminated
- April 16, 2020
- Recall Number
- Z-0816-2018
- Quantity
- 55
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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.