Mindray DP-30 Ultrasound Systems Recalled for Incorrect Needle-Guide Display
Mindray is recalling 53 DP-30 ultrasound systems and 18 USB drives because the devices display an incorrect needle-guide bracket when used with a specific transducer.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a software display error that may affect procedural accuracy, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Mindray DS USA, Inc. is recalling 53 DP-30 Digital Ultrasonic Diagnostic Imaging Systems and 18 USB drives containing affected software. The recall affects systems running software versions 03.00.00 and 03.01.00.
The recall is due to a software defect where the DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer. This issue may affect the accuracy of the visual guide used during procedures.
The affected products were distributed nationwide in California, Georgia, Illinois, Maryland, New York, South Carolina, and Washington. Healthcare facilities and users should stop using the affected systems with the 65EC10EA transducer and contact Mindray for instructions on software updates or repairs.
The recalled product
- 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…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- DP-30 Ultrasound with software version 03.00.00 and 03.01.00
Distribution
Related recalls
Same manufacturer · Mindray DS USA, Inc. dba Mindray North America
See all →- HighCentral monitoring workstations recalled over audio failure and screen freezing
FDA (Devices) · 2025-12-24
- HighAnesthesia vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighIsoflurane vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighPatient monitors recalled over potential activation of an abnormal alarm pause
FDA (Devices) · 2025-10-01
- HighSevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction
FDA (Devices) · 2024-09-11
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighMindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies
FDA (Devices) · 2018-10-24
- HighMindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly
FDA (Devices) · 2013-02-20
- HighMindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors
FDA (Devices) · 2014-07-23
- HighFDA Recalls Defective Ultrasound Needles That May Leak at Hub
FDA (Devices) · 2014-05-21
- ModerateCapso Vision Recalls CapsoCam Plus Capsule Endoscopy Systems Due to Labeling Errors
FDA (Devices) · 2020-05-27
- ModerateMedisystems Buttonhole Needle Set Recalled for Mislabeled Length
FDA (Devices) · 2013-01-30