openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Vital Sync" VPMP & IM, software, V2.4. (DVD), 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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Model # 10007101; Lot # 14A0041IN
Distribution pattern
US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
device · product 2 of 2
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Model # 10116080 ; Lot # PO643063
Distribution pattern
US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
