| Class 2 Device Recall Dixtal Handheld Pulse Oximetry | |
Date Initiated by Firm | September 27, 2010 |
Date Posted | December 09, 2010 |
Recall Status1 |
Terminated 3 on August 04, 2016 |
Recall Number | Z-0551-2011 |
Recall Event ID |
57045 |
510(K)Number | K032949 |
Product Classification |
Oximeter - Product Code DQA
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Product | Dixtal Handheld Pulse Oximetry Model 512
Catalog Number: 9100-00 |
Code Information |
Serial Number: 125-33239, 125-33265, 125-33236, 125-33234 |
Recalling Firm/ Manufacturer |
Dixtal Medical, Inc. 101 N Plains Industrial Rd Bldg 2 Wallingford CT 06492-2360
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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 | 4 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 |
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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 = DQA
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