Mindray DS USA, Inc. dba Mindray North America recalls DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No.
Recalled 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.
Hazard / Issue
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Issued by
FDA
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