# FDA recall Z-1330-2020

> **Mindray DS USA, Inc. dba Mindray North America** · Class II · device recall initiated 2020-01-13.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1330-2020
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-13
- **Report date:** 2020-02-26
- **Termination date:** 2020-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2020

## Citation

> AI Analytics. FDA recall Z-1330-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1330-2020. Source: US FDA. Licensed CC0.

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