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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Manufacturer
- Hitachi Medical Systems America Inc
- Hazard
- Affected units
- 55
Distribution
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