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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84794

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 13, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mindray DS USA, Inc. dba Mindray North America

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1330-2020
Initiated
January 13, 2020
Classification
Class II
Status
Terminated
Quantity
53 DP-30 systems and 18 USB's containing the affected software

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.