Mindray DPM 6 Patient Monitor Recalled for Uncleared ST/Arrhythmia Feature
Mindray DS USA is recalling four DPM 6 patient monitors in Ohio because the included Multi Parameter Module contains a cardiac ST/Arrhythmia analysis feature that is not cleared for marketing.
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. The hazard is a regulatory compliance issue (uncleared feature) rather than a direct physical defect causing injury, and no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling four units of the DPM 6 Monitor in use with a Multi Parameter Module (MPM). The product is a patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters, including ECG, heart rate, respiration rate, and blood pressure.
The recall is being conducted because the MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. The affected units were distributed nationwide in the state of Ohio. The specific product codes are monitor p/n 6802F-PA00001 and module p/n 115-001704-00/M51A-30-80876.
Healthcare facilities and users should contact Mindray DS USA for instructions on how to resolve the issue with the uncleared feature. The source text does not specify a specific action such as return or repair, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP)…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Affected units
- 4
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)
- monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876
Distribution
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