Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch
Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.
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, which typically indicates a temporary or medically reversible adverse health consequence. The source describes a software mismatch affecting alarm priorities without reporting specific injuries or deaths, fitting the criteria for a moderate severity field correction.
Plain-English summary
Nellcor Puritan Bennett Inc. (dba Covidien LP) is conducting a field correction for the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager. The recall involves 9 units of Vital Sync RMS 1.0 loaded with v2.4 software, packaged on a CD or other electronically controlled device. The specific model number is 10116080 and the lot number is PO643063.
The reason for the field correction is a mismatch between the alarm priority on the medical devices and the Vital Sync system. The platform is intended for healthcare professionals to remotely consult on patient status and review near real-time patient data, waveforms, and alarms to aid in clinical decisions.
The affected units were distributed in the United States to the states of Louisiana, Illinois, Mississippi, Colorado, Indiana, Georgia, California, and Texas. Healthcare professionals using this software should contact the manufacturer for instructions on the field correction.
The recalled product
- Product
- Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare…
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- 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 (2)
- Model # 10116080
- Lot # PO643063
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) 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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