Mindray DS USA, Inc. dba Mindray North America recalls DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diag…

Recall date

January 13, 2020

Source

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

Recall number

Z-1330-2020

FDA classification

Class II

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.

Why it was recalled

The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.

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

What was recalled

DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.