Medical device recalls Moderate risk

Hitachi Medical Systems America Inc recalls Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultra…

Recall date
May 2, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2090-2017
FDA classification
Class II
Brand / firm
Hitachi Medical Systems America Inc
Sold / distributed
Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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