DP-30 Digital Ultrasonic Diagnostic Imaging System — Class II medical device recall Z-1330-2020
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2020-02-26, distributed nationwide. The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
| Recall number | Z-1330-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2020-01-13 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Model numbers | 1155E-PA00004 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1330-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.