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 professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model # 10116080 ; Lot # PO643063
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Reason for Recall:
- Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
Product Codes/Lot Numbers:
Model # 10116080 ; Lot # PO643063
Distribution:
Distributed in: US, LA, IL, MS, CO, IN, GA, CA, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2235-2014
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Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.