FDA recall Z-1330-2020

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.

Reason for recall

The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.

Distribution

US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.

Key facts

Status

Terminated

Initiation date

2020-01-13

Report date

2020-02-26

Termination date

2020-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2020