Drug recall
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the…
FDA recall event 77051 · Class II · Hitachi Medical Systems America Inc
Key facts
| Event ID | 77051 |
|---|---|
| Recall numbers | Z-2090-2017 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Product type | Devices |
| Products | Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The strength of the arm mounting mechanism was insufficient and had to be redesigned. |
| Initiation date | May 2, 2017 |
| Report date | May 24, 2017 |
| Termination date | Nov 19, 2018 |
| City | Twinsburg |
| State | OH |
| Country | United States |
| FEI number | 1528028 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: