Arietta 70 Ultrasound System Intended for use by trained personnel — Class II medical device recall Z-2090-2017
Terminated recall by Hitachi Medical Systems America Inc, reported 2017-05-24, distributed in AZ, CA, FL, HI, IL, MA, MD, ME…. The strength of the arm mounting mechanism was insufficient and had to be redesigned.
| Recall number | Z-2090-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Medical Systems America Inc, Twinsburg, OH, United States |
| Recall initiated | 2017-05-02 |
| Classified | 2017-05-12 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2018-11-19 |
| Distributed | AZ, CA, FL, HI, IL, MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX |
| Quantity | 77 |
| Reason classes | potency |
Product
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Reason for recall
The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2090-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.