Recall Z-1330-2020 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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 (convent
| Date | Feb 5, 2020 (initiated Jan 13, 2020) |
| Status | Terminated |
| 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 versio |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183660 | DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Apr 9, 2019 |