FDA-Device2020-02-26Class II
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.
Mindray DS USA, Inc. dba Mindray North America
Hazard
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Sold states
US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
Affected count
53 DP-30 systems and 18 USB's containing the affected software
Manufactured in
800 Macarthur Blvd, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2020Don't want to check this manually?
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