Food, drugs, devices › Mindray DS USA, Inc. dba Mindray North America
Device recall: DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagn
FDA enforcement event 84794 is a device recall by Mindray DS USA, Inc. dba Mindray North America of Mahwah, NJ, initiated 13 Jan 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 21 Aug 2020. Initiation: voluntary: firm initiated. Mindray DS USA, Inc. dba Mindray North America has 29 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1330-2020 | 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… | 53 DP-30 systems and 18 USB's containing the affected software | Class II | Terminated | 26 Feb 2020 |
Context
Other enforcement events for Mindray DS USA, Inc. dba Mindray North America
All 29 events for Mindray DS USA, Inc. dba Mindray North America
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.