Recall Z-1526-2008 ยท CBK Ventilator, Continuous, Facility Use
Datex - Ohmeda, Inc
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe.
| Date | Aug 16, 2008 (initiated Jul 2, 2007) |
| Status | Terminated |
| Reason | Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a Medical Device Correction Notification letter on July 2, 2007. The firm's short term recommendation is that Neonatal Flow Sensors may continue to be used with added viligance around potential patient circuit disconnections and the associated alarms. Ther firm recommends that the MV exp high and Circuit leak alarms be set appropriately for each patient in order to detect a patient disconnect. The long term recommendation was to order the replacement part when available and dispose of the old part when the replacement is received. |
| Quantity | 394 |
| Distribution | Worldwide Distribution --- USA including state of TX and countries of Austria, Bangladesh, Belgium, Costa Rica, Denmark, Finland, France, Germany, India, Italy, Mexico, Saudi Arabia, South Africa, Sweden, Switzerland, United Kingdom, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062710 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc., Dec 8, 2006 |