Recall Z-0784-2007 ยท CBK Ventilator, Continuous, Facility Use
Datex - Ohmeda, Inc
GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.
| Date | May 10, 2007 (initiated Feb 2, 2007) |
| Status | Terminated |
| Reason | There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset. |
| Root cause | Other |
| Action | Device Correction Letter to customers was mailed on 2/2/07 giving information about the correction and a short term recommendation until version 4.15 could be installed by a GE representative who would be contacting the customer. |
| Quantity | 446 |
| Distribution | GA, RI, WI, TX. Foreign - AUSTRALIA, BRUNEI DARUSSALAM, BRAZIL, COLOMBIA, COSTA RICA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDIA, ITALY, KOREA, MEXICO, MALAYSIA, PHILIPPINES, SAUDI ARABIA, SWEDEN, SINGAPORE, GERMANY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060862 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc., Jun 5, 2006 |