Z-1330-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- January 13, 2020
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 DP-30 systems and 18 USB's containing the affected software
Product Description
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.
Reason for Recall
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Distribution Pattern
US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
Code Information
DP-30 Ultrasound with software version 03.00.00 and 03.01.00