Mindray DS USA, Inc. dba Mindray North America 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mindray DS USA, Inc. dba Mindray North America
Lot Codes / Batch Numbers
DP-30 Ultrasound with software version 03.00.00 and 03.01.00
Products Sold
DP-30 Ultrasound with software version 03.00.00 and 03.01.00
Mindray DS USA, Inc. dba Mindray North America is recalling DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digi due to The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Recommended Action
Per FDA guidance
On January 13, 2020, the firm distributed Urgent Medical Device Correction letters to affected distributors. Distributors were informed that the system displays the incorrect needle-guide bracket when used with the 65EC10EA model transducer. Customers were advised to avoid use of NGB-004 needle-guide with transducer model 65EC10EA until a software update has been applied to the system. The system may be used normally for all other functions. The firm recommended that distributors immediately notify any clients to which they have distributed affected systems (DP-30 systems with software version 03.00.00 and 03.01.00 distributed between 06/25/2018 and 06/28/2019), or provided a software update (USB with V03.01.00, part number 110-002261-05). Within the next several weeks, Mindray will provide a software update at no cost. Should you require technical assistance while performing the update, please contact Mindrays Technical Support team at 800-288-2121, option 2, Monday through Friday, 8:30am - 5:30pm PT. The replacement USB drive contains instructions on how to perform the software update, under the Manuals folder in the DP-10 & DP-20 & DP-30 Series System Recovery Guide file. If you have questions regarding this recall, you may contact Diane Arpino, Director, Quality Operations and Regulatory Affairs, at 201-995-8407, or via email at d.arpino@mindray.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026