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Mindray DS USA, Inc. dba Mindray North America recalls DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagn
Recalled February 26, 2020 · FDA recall Z-1330-2020 · Mindray DS USA, Inc.
Hazard
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer. · FDA Class II
Units
53 DP-30 systems and 18 USB's containing the affected software
Sold at
US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
Description
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
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.
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →