The Recall Desk
HighFDA (Devices)·Z-0816-2018·Announced 2018-03-07

Hitachi Ultrasound Transducer Recalled for Electrical Shock Hazard

Hitachi Medical Systems America Inc is recalling 55 ultrasound transducers (Model UST-5550-R) because they may not have adequate protection against electrical shock hazards.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical shock) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Hitachi Medical Systems America Inc is recalling 55 units of the Ultrasound Transducer, Model Number UST-5550-R. This device is used in conjunction with a diagnostic ultrasound system for evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

The recall is being issued because the ultrasound probe may not have adequate protection against electrical shock hazards. The affected units were distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, and WV.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any specific injuries or illnesses associated with the defect.

The recalled product

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.
Affected units
55

Distribution

Same manufacturer · Hitachi Medical Systems America Inc

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