Mindray Rosie4 Vital Signs Monitor Recalled for Software Clearance Issues
Mindray is recalling 14 Rosie4 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, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a regulatory compliance issue regarding software features not included in the marketing clearance, which fits the criteria for a moderate severity score.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 14 units of the Rosie4 Vital Signs Monitor. The recall involves the NIBP valve assembly board, part number 115-017679-00, which contains software version 8.1.5. The affected monitors were distributed nationwide in the United States.
The recall was initiated because the NIBP valve assembly board includes enhancements that are not included in the current marketing clearance. Specifically, the software contains an anti-motion feature and a NIBP hose blockage identification function that were not part of the original clearance.
The monitors are intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP), and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities. The source text does not report any illnesses, injuries, or adverse events associated with this recall.
The recalled product
- Product
- Rosie4 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 monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Te
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Affected units
- 14
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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