Z-1330-2020Class II

DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 -

Name: Z-1330-2020 DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 -
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2020-01-13
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2020-01-13 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for... on 2020-01-13. FDA classified it as Class II and gives the reason as "The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1330-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-13
Posted: 2020-02-05
Terminated: 2020-08-21
Recalling firm: Datascope Corp.
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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Root cause tag: software
FDA 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 version 03.00.00 and 03.01.00 distributed between 06/25/2018 and 06/28/2019), or provided a software update (USB with V03.01.00, part number 110-002261-05). Within the next several weeks, Mindray will provide a software update at no cost. Should you require technical assistance while performing the update, please contact Mindrays Technical Support team at 800-288-2121, option 2, Monday through Friday, 8:30am - 5:30pm PT. The replacement USB drive contains instructions on how to perform the software update, under the Manuals folder in the DP-10 & DP-20 & DP-30 Series System Recovery Guide file. If you have questions regarding this recall, you may contact Diane Arpino, Director, Quality Operations and Regulatory Affairs, at 201-995-8407, or via email at [email protected].
Quantity in commerce: 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.
Product codes and lots: DP-30 Ultrasound with software version 03.00.00 and 03.01.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1330-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1330-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-20

Product code IYN

K183660Class IIDP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2019-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)