Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2020 - (Recall #: Z-1330-2020)

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:

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.

Product Classification:

Class II

Date Initiated: January 13, 2020

Date Posted: February 26, 2020

Recall Number: Z-1330-2020

Event ID: 84794

Reason for Recall:

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

Status: Terminated

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

Code Information:

DP-30 Ultrasound with software version 03.00.00 and 03.01.00

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated