Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DP-30 Digital Ultrasonic Diagnostic Imaging System Recalled by Mindray DS USA, Inc. dba Mindray North America Due to The DP-30 displays an incorrect needle-guide bracket when...

Date: January 13, 2020
Company: Mindray DS USA, Inc. dba Mindray North America
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mindray DS USA, Inc. dba Mindray North America directly.

Affected Products

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.

Quantity: 53 DP-30 systems and 18 USB's containing the affected software

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America has 39 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report