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Use caution Medical device recall · FDA · Published October 20, 2017

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

Hitachi Medical recalls UST-5550-R ultrasound transducers used in surgical procedures due to risk of electrical shock. Affected units may cause injury during medical procedures.

🇺🇸 FDA recall #Z-0816-2018Medical deviceHitachi Medical ›
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Contact the company

Recalling firmHitachi Medical Systems America Inc1959 Summit Commerce Park · Twinsburg, OH 44087-2371
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/72775-hitachi-medical-ust-5550-r-ultrasound-probe-recall-electrical-shock.

Source Summary by GovInfoNow · govinfonow.com/recall/72775-hitachi-medical-ust-5550-r-ultrasound-probe-recall-electrical-shock · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0816-2018

Cite this page

“Hitachi Medical UST-5550-R Ultrasound Probe Recall: Electrical Shock Hazard.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72775-hitachi-medical-ust-5550-r-ultrasound-probe-recall-electrical-shock. Based on FDA recall #Z-0816-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0816-2018%22&limit=1).

The FDA announced on 2017-10-20 that Hitachi Medical Systems America Inc is recalling the Model UST-5550-R Ultrasound Transducer due to inadequate protection against electrical shock hazards. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Hitachi Medical
  • Product: Ultrasound Transducer
  • Model Number: UST-5550-R
  • Units affected: 55

The hazard

The ultrasound probe may not have adequate protection against electrical shock hazards, according to the FDA.

Context

GovInfoNow's records show Hitachi Medical Systems America Inc has 5 other recalls on record since 2018-06-18. Other recent recalls of similar products include Sheathes3D Viral Barrier Ultrasound Probe Covers Recall (2025-11-17), GE Medical Systems Allia IGS 7 Pulse X-Ray System Recall (2026-04-20) and GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall (2026-04-20).

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

  1. Check for Model Number

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

Where it went and when

Where it was distributed

Distributed in 21 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Massachusetts, Missouri, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Oct 20, 201712. FDA classified it Class II: Mar 1, 201823. Published in FDA’s Enforcement Report: Mar 7, 201834. FDA terminated the recall: Apr 16, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA