Reported Feb 26, 2020 · Terminated
DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic…
Mindray DS USA, Inc. dba Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. dba Mindray North America · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 -
- Product UsageThe 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
- Lot codes and dates
- DP-30 Ultrasound with software version 03.00.00 and 03.01.00
- Amount recalled
- 53 DP-30 systems and 18 USB's containing the affected software
Where it was sold
Why it was recalled
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
This product could cause temporary or reversible health problems — stop using it.
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