Class 2 Device Recall DP30 Digital Ultrasonic Diagnostic Imaging System

• Date Initiated by Firm: January 13, 2020
• Date Posted: February 05, 2020
• Recall Status: Terminated on August 21, 2020
• Recall Number: Z-1330-2020
• Recall Event ID: 84794
• 510(K)Number: K183660
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• 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.
• Code Information: DP-30 Ultrasound with software version 03.00.00 and 03.01.00
• Recalling Firm/ Manufacturer: Mindray DS USA, Inc. dba Mindray North America; 800 Macarthur Blvd; Mahwah NJ 07430-2001
• For Additional Information Contact: Diane Arpino; 201-995-8407
• Manufacturer Reason for Recall: The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYN and Original Applicant = Shenzhen Mindray Bio-Medical Electronics Co., LTD