Drug recall
UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for…
FDA recall event 84838 · Class II · Hitachi Medical Systems America Inc
Key facts
| Event ID | 84838 |
|---|---|
| Recall numbers | Z-1341-2020 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Product type | Devices |
| Products | UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings. |
| Initiation date | Jan 31, 2020 |
| Report date | Feb 26, 2020 |
| Termination date | Jul 31, 2020 |
| 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: