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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