Mindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations
Mindray DS USA is recalling 124 DPM 6 and 7 patient monitors because specific calculation features may be unavailable.
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, but the source text explicitly states no illnesses or injuries are reported and the hazard is limited to unavailable software features, fitting the criteria for a moderate severity score.
Plain-English summary
Mindray DS USA, Inc. is recalling 124 units of DPM 6 and DPM 7 patient monitors. These devices are intended for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters, including ECG, heart rate, respiration rate, and blood pressure.
The recall is due to an issue where the following features may be unavailable: Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations. The affected units were distributed nationwide in the United States, including in Washington, Illinois, Florida, Minnesota, South Carolina, Nevada, Michigan, Tennessee, Pennsylvania, Louisiana, Nebraska, Texas, and Iowa.
Healthcare facilities should contact Mindray DS USA for further instructions regarding the recall. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or…
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 124
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)
- K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001
Distribution
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