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Hitachi America, Ltd., Particle Therapy Division FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. Matched by name to HTHIY.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: ThClass IIMay 27, 2024During positioning within the system's 3D to 3D matching mod
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: TheClass IIMay 27, 2024During positioning within the system's 3D to 3D matching mod
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: ThClass IIMay 27, 2024During positioning within the system's 3D to 3D matching mod

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