FDA Medical Device Recalls (openFDA)
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 number
- Z-1330-2020
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- 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.
- Status
- Terminated
- Initiated
- 2020-01-13
- Posted
- 2020-02-05
- Terminated
- 2020-08-21
- Reason
- The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
- Root cause
- Software Design Change
- Action
- 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.
- Quantity
- 53 DP-30 systems and 18 USB's containing the affected software
- Distribution
- US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
- Lot, serial or model codes
- DP-30 Ultrasound with software version 03.00.00 and 03.01.00
- 510(k) numbers
- ["K183660"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28