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
107108109114115116118120121122126129130132135139140141143144147148151155
- 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
- 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.
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