FDA-Device2017-05-24Class II

Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

Hitachi Medical Systems America Inc
Hazard

The strength of the arm mounting mechanism was insufficient and had to be redesigned.

Sold states
Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.
Affected count
77
Manufactured in
1959 Summit Commerce Park, Twinsburg, OH, United States
Products
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2090-2017

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