FDAClass IIFebruary 26, 2020

DP-30 Digital Ultrasonic Diagnostic Imaging System recall

DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is…

Why was DP-30 Digital Ultrasonic Diagnostic Imaging System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

DP-30 Ultrasound with software version 03.00.00 and 03.01.00

Product
DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is…
Recalling firm
Mindray DS USA, Inc. dba Mindray North America
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.
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls