Hitachi Medical Systems America Inc: Medical Device Recall in 2020 - (Recall #: Z-1341-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 31, 2020

Date Posted: February 26, 2020

Recall Number: Z-1341-2020

Event ID: 84838

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.

Status: Terminated

Product Quantity: 18

Code Information:

Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900

Distribution Pattern:

Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated