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.
What this means for you
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 org
- 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
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