Recall Z-2235-2014 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Nellcor Puritan Bennett Inc. (dba Covidien LP)
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-tim
| Date | Aug 14, 2014 (initiated Jul 17, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | The firm, Covidien, sent an "URGENT FIELD CORRECTIVE ACTION NOTICE" letter dated 7/16/14 to its customers on 7/17/14 via FedEx. The letter informs users that a representative will be in contact to schedule a software update.The letter also described the product, problem and actions to be taken. The customers were instructed to disregard the audible and visual alarm priority indicators and only use the alarm description text on the patient tile and on the patient detail page for alarm priority information, until the mismatch is corrected. The Vital Sync" Virtual Patient Monitoring Platform and |
| Quantity | 9 |
| Distribution | US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX. |
| FDA record | Open on fda.gov |