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.
This recall has been terminated (originally issued May 10, 2007).
- Company
- Datex Ohmeda, Inc
- Recall Initiated
- February 2, 2007
- Posted
- May 10, 2007
- Terminated
- October 16, 2008
- Recall Number
- Z-0784-2007
- Quantity
- 446
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Serial numbers: CBCH00101, CBCH00110, CBCJ00135, CBCJ00136, CBCJ00207, CBCJ00472, CBCJ00623, CBCJ00685, CBCJ00686, CBCJ00688 thruCBCJ00702, CBCK00100, CBCK00101 thru CBCK00208, CBCK00210 thru CBCK00269, CBCK00271 thru CBCK00298, CBCK00301 thru CBCK00516, CBCK00519 thru CBCK00526, CBCK00535
Root Cause
Other
Action Taken
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.