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U.S. Department of Health and Human Services

Class 2 Device Recall Tec 7 Vaporizer

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  Class 2 Device Recall Tec 7 Vaporizer see related information
Date Initiated by Firm October 04, 2017
Create Date March 26, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-1198-2018
Recall Event ID 79493
510(K)Number K012924  
Product Classification Vaporizer, anesthesia, non-heated - Product Code CAD
Product DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER

Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
Code Information Model # M1107626 Mfg. Lot or Serial #: BEJN05568, BEJM03853, BEJM04539, BEJN05793, BEJP01947, BEJP03924, BEJP04380, BEJP08533, BEJU06631, BEJN06095, BEJP04706, BEJU05053, BEJM04542, BEJM04881, BEJM04901, BEJN07748, BEJN07849, BEJP03230, BEJP03239, BEJP03559, BEJP03984, BEJP05309, BEJP05347, BEJP05825, BEJP05834, BEJP05978, BEJP08567, and BEJP09304. 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
FDA Determined
Cause 2		 Process control
Action The firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative.
Quantity in Commerce 28
Distribution US Distribution to states of: AZ, IL NC, NH and PA.
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 = CAD and Original Applicant = DATEX-OHMEDA, INC.
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