Reported Mar 7, 2018 · Terminated

Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation…

Hitachi Medical Systems America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hitachi Medical Systems America Inc · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371

Is this the product you have?

  • Ultrasound Transducer
  • Model NumberUST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures
Lot codes and dates
  • 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
Amount recalled
55

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Hitachi Medical Systems America Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 16, 2020 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.