Hitachi Medical UST-5550-R Ultrasound Probe Recall: Electrical Shock Hazard

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Contact the company & request your remedy

Recalling firmHitachi Medical Systems America Inc1959 Summit Commerce Park, N/A · Twinsburg, OH 44087-2371

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Hitachi Medical is recalling ultrasound transducers with model number UST-5550-R that are used in surgical procedures. These devices may not have adequate protection against electrical shock, which could cause injury during medical procedures.

Why it’s dangerous

The ultrasound probe may not have adequate electrical insulation, increasing the risk of electrical shock. This could happen during surgical procedures when the device is in contact with bodily fluids or tissues.

Who’s affected

Healthcare professionals using the ultrasound transducer during surgical procedures are most at risk. Patients undergoing procedures with this device could also be affected.

How to tell if you have this one

Check for the model number UST-5550-R on the ultrasound transducer. These devices are used with diagnostic ultrasound systems during surgical procedures.

Brand
Hitachi Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Model Number
Look for the model number UST-5550-R on the ultrasound transducer.

✎ GovInfoNow

Questions people ask

What is the hazard with this ultrasound probe?

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

Is there a fix for this issue?

The recall record does not specify a remedy.

Who is affected by this recall?

Healthcare professionals using the ultrasound transducer during surgical procedures.

Take action

Contact Hitachi Medical

We’ve drafted a message you can send Hitachi Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0816-2018 — Hitachi Medical Hitachi Medical

Hello,

I own a Hitachi Medical that is covered by recall Z-0816-2018 from Hitachi Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0816-2018 (October 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0816-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Hitachi Medical Systems America Inc recalls Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation

Use caution until it’s fixed