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U.S. Department of Health and Human Services

Class 2 Device Recall Dixtal Handheld Pulse Oximetry

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  Class 2 Device Recall Dixtal Handheld Pulse Oximetry see related information
Date Initiated by Firm September 27, 2010
Date Posted December 09, 2010
Recall Status1 Terminated 3 on August 04, 2016
Recall Number Z-0550-2011
Recall Event ID 57045
510(K)Number K032949  
Product Classification Oximeter - Product Code DQA
Product Dixtal Handheld Pulse Oximetry Model 513
Catalog Number: 9300-00
Code Information Serial Numbers: 139-31479, 139-31485, 139-31465 TO 139-31478,  139-31483 AND 139-31489, 139-31490, 139-31493,  139-31494, 139-31499, 139-31511, 139-31514, 139-31515, 139-31522, 139-31526 & 139-31529, 139-31487, 139-31512 139-31480, 139-31463, 139-31486, 139-31491, 139-31462 
Recalling Firm/
Manufacturer		 Dixtal Medical, Inc.
101 N Plains Industrial Rd Bldg 2
Wallingford CT 06492-2360
For Additional Information Contact SAME
203-269-1112 Ext. 226
Manufacturer Reason
for Recall		 Unit may overestimate Sp02 levels in a high humidity environment.
FDA Determined
Cause 2		 Equipment maintenance
Action Dixtal Medical notified accounts by email on 9/27/10 and followed by hard copy Urgent Product Recall letter, dated September 27, 2010. The letter identified the affected product and stated the reason for the recall. The letter also requested that customers to cease distribution and/or use of the suspect product and to return product for replacement. The attached Confirmation Notification should be completed and returned. Customers are to contact Customer Service: sales@dixtal.com, Phone 1-203-269-1112, Fax 1-203-269-1760, with questions or to arrange to have a replacement product provided.
Quantity in Commerce 35 units
Distribution Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia, Canada, Finland, Indonesia, Italy, Poland, Sweden, and Switzerland.
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 = DQA and Original Applicant = RESPIRONICS NOVAMETRIX, INC.
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