Recall Z-0262-2008 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Edwards Lifesciences, Llc
Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA 92614
| Date | Nov 24, 2007 (initiated May 17, 2007) |
| Status | Terminated |
| Reason | MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25mmHg. Since the MAP is used in calculations of various patient parameters such as SVR, |
| Root cause | Software design |
| Action | An Urgent Customer notification letter dated May 17, 2007 was mailed to all Vigilance II customers advising that If they are "slaving" mean arterial pressure (MAP) from their bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), to be aware that at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25 mmHg. Since the MAP is used in calculations of various patient parameters such as SVR, these may also not be accurate. A table is provided showing those bedside monitors wit |
| Quantity | 2,680 units in North America distribution |
| Distribution | Worldwide: USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043103 | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 Edwards Lifesciences, LLC, Dec 9, 2004 |