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U.S. Department of Health and Human Services

Class 2 Device Recall Engstrom Carestation

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  Class 2 Device Recall Engstrom Carestation see related information
Date Initiated by Firm February 02, 2007
Date Posted May 10, 2007
Recall Status1 Terminated 3 on October 16, 2008
Recall Number Z-0784-2007
Recall Event ID 37105
510(K)Number K060862  
Product Classification Critical Care Ventilator - Product Code CBK
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Datex - Ohmeda, Inc
3030 Ohmeda Drive
PO Box 7550, zip 53707-7550
Madison WI 53707-7550
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DATEX-OHMEDA, INC.
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