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U.S. Department of Health and Human Services

Class 2 Device Recall EZchange Module

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  Class 2 Device Recall EZchange Module see related information
Date Initiated by Firm July 24, 2007
Date Posted October 04, 2007
Recall Status1 Terminated 3 on October 16, 2015
Recall Number Z-0006-2008
Recall Event ID 38484
Product Classification anesthesia system component - Product Code BSF
Product GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.
Code Information EZchange Manifold with part number 1407-7021-000,  1407-7027-000, M1053007, M1053008. 
Recalling Firm/
Manufacturer		 Datex - Ohmeda, Inc
Po Box 7550
Madison WI 53707
Manufacturer Reason
for Recall		 Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.
FDA Determined
Cause 2		 Vendor change control
Action Because this issue only occurs when the Disposable Multi Absorber is used in conjunction with EZchange Module, they have contacted all EZchange Module customers. It is critical to contact these customers specifically, rather than all customers shipped Disposable Multi Absorbers as this may cause unwarranted confusion with customers who do not have the EZchange Module. Consignees were sent an letter dated 7/19/2007 describing the product and problem. The letter lists a number of interim actions to implement with the anesthesia systems.
Quantity in Commerce 389,070
Distribution Worldwide, including USA, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, Estonia, Finland, France, Germany, India, Ireland, Italy, Jordan, Republic of Korea, Kuwait, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Qatar, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and Venezuela.
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.
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