Mindray Rosebud Vital Signs Monitor Recalled for Unapproved Software Features
Mindray is recalling 9 Rosebud Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 9 units of the Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5. The product is intended for spot-check monitoring of physiologic parameters, including Pulse Oximetry, Pulse Rate, Non Invasive Blood Pressure, and Temperature, on adult, pediatric, and neonatal patients in healthcare facilities.
The recall is due to the NIBP valve assembly board containing enhancements that are not included in the current marketing clearance. Specifically, the software includes an anti-motion feature and a NIBP hose blockage identification function that were not part of the approved clearance.
The affected units were distributed nationwide in the United States. Healthcare facilities should contact Mindray DS USA, Inc. dba Mindray North America for instructions on how to proceed with the recall.
The recalled product
- Product
- Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressur
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 9
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 (3)
- NIBP valve assembly board
- p/n 115-017679-00
- containing software version 8.1.5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Mindray DS USA, Inc. dba Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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