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Recall Observatory FDA recall evidence

Device 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.

Z-0816-2018

October 20, 2017

Class II

Product summary

Firm
Hitachi Medical Systems America Inc
Event
Event 79160
Status
Terminated
Classification
Class II
Quantity
55
Official record key
device-enforcement:Z-0816-2018

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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