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Class 2 Device Recall Engstrom Carestation |
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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
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Product Classification |
Critical Care Ventilator - Product Code CBK
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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
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = CBK and Original Applicant = DATEX-OHMEDA, INC.
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