Recall Z-2201-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
| Date | Sep 16, 2013 (initiated Jul 20, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th |
| Root cause | Software design |
| Action | Consignees were sent on 7/20/2011 a GE Healthcare "Important Product Information" letter. The letter was addressed to Healthcare Administrator / Risk Manager, chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Instructions, Product Correction, and Contact Information (Technical Support 1-800-558-7044). |
| Quantity | 636 (53 US, 583 OUS) |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPOR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092027 | CARESCAPE MONITOR B850 Ge Medical Systems Information Technologies, Aug 28, 2009 |