• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Dixtal Handheld Pulse Oximetry

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Dixtal Handheld Pulse Oximetry
see related information
Date Posted December 09, 2010
Recall Status1 Open
Recall Number Z-0551-2011
Recall Event ID 57045
Premarket Notification
510(K) Number
K032949 
Product Classification Oximeter - Product Code DQA
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, Connecticut 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
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = RESPIRONICS NOVAMETRIX, INC.
-
-