Mindray Accutorr 7 Vital Signs Monitor Software Recall
Mindray is recalling 107 Accutorr 7 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, and the source text describes a regulatory compliance issue regarding software features not included in the marketing clearance, without reporting any specific injuries or illnesses.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 107 units of the Accutorr 7 Vital Signs Monitor. The recall involves the NIBP valve assembly board, part number 115-017679-00, which contains software version 8.1.5. These monitors are intended for monitoring physiologic parameters, including Pulse Oximetry, Pulse Rate, Non Invasive Blood Pressure, Temperature, and Carbon Dioxide on adult, pediatric, and neonatal patients in professional healthcare facilities.
The recall is being conducted because the NIBP valve assembly board subject to the recall includes 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 and users should contact the recalling firm for instructions on how to address the software discrepancy.
The recalled product
- Product
- Accutorr 7 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
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- Affected units
- 107
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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