FDA Device recall Z-1341-2020
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…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of 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… by Hitachi Medical Systems America, citing these 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1341-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-31 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | CA, FL, GA, MA, NV, OH, TX, WV |
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
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
Identifiers
| code_info | Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206…Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1341-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.