CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
DP-30 Digital Ultrasonic Diagnostic Imaging System recalled
Mindray DS USA is recalling DP-30 Digital Ultrasonic Diagnostic Imaging System, distributed nationwide in the US. The recall was initiated on 13 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1330-2020
- FDA event ID
- 84794
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2020
- FDA classified
- 20 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 13 Jan 2020 | Recall initiated by company | |
| 20 Feb 2020 | Classified by FDA | +38 days |
| 26 Feb 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
Nationwide CaliforniaGeorgiaIllinoisMarylandNew YorkSouth CarolinaWashington
Questions about this recall
Why was it recalled?
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Which lots are affected?
DP-30 Ultrasound with software version 03.00.00 and 03.01.00
Where was it sold?
US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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