Device 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.
Z-1330-2020
Product summary
- Event
- Event 84794
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53 DP-30 systems and 18 USB's containing the affected software
- Official record key
device-enforcement:Z-1330-2020
Official wording
Reason: The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Code information: DP-30 Ultrasound with software version 03.00.00 and 03.01.00
Distribution pattern: US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
Derived failure modes
-
Unknown
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.