UST-2265-2 Probe — Class II medical device recall Z-1341-2020
Terminated recall by Hitachi Medical Systems America Inc, reported 2020-02-26, distributed in CA, FL, GA, MA, NV, OH, TX, WV. These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in l
| Recall number | Z-1341-2020 |
|---|---|
| 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 | 2020-01-31 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2020-07-31 |
| Distributed | CA, FL, GA, MA, NV, OH, TX, WV |
| Countries outside the US | CA |
| Quantity | 18 |
| Serial numbers | 205X3897, 205X3898, 205X3899, 205X3900, 206H2620, 206H2621, 206H2622, 206H26224, 206H2623, 206H2625, 206H2626, 206H2627, 206H2628, 206H2629, 206H2630, G3007687, G3007688, G3007689 |
| Model numbers | UST-2265-2 |
Product
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 Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
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.
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-1341-2020. 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.