FDA Device recall Z-1330-2020
DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging Syste…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging Syste… by Mindray Ds Usa, citing the DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1330-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-13 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
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
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Identifiers
| code_info | DP-30 Ultrasound with software version 03.00.00 and 03.01.00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2020%22
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