Hitachi Medical Systems America Inc recalls UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic u…

Recall date

January 31, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1341-2020

FDA classification

Class II

Brand / firm

Hitachi Medical Systems America Inc

Sold / distributed

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

Why it was recalled

These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.