Mindray Recalls IBP Modules for DPM 6 and DPM 7 Patient Monitors
Mindray is recalling IBP modules for DPM 6 and DPM 7 patient monitors because blood pressure data may display in the wrong screen tile.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a display error could lead to misinterpretation of patient data, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Mindray DS USA, Inc. is recalling 455 units of the IBP module (P/N 6800-30-50-50485) used with the DPM 6 and DPM 7 patient monitors. The recall was initiated because the module may display invasive blood pressure (IBP) measurement data in an incorrect tile on the monitor's display.
The affected modules were distributed to hospitals and healthcare facilities in Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Mississippi, Montana, North Carolina, North Dakota, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington, and West Virginia.
Healthcare facilities should stop using the affected IBP modules and contact Mindray for further instructions on the recall process.
The recalled product
- Product
- DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Affected units
- 455
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 (2)
- DPM 6 - PN: C-047-000199-00 and DPM 7 - PN: C-047-000200-00
- IBP Module P/N: 6800-30-50485
Distribution
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