Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Sonotrax

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


New Search Back to Search Results
  Class 2 Device Recall Sonotrax see related information
Date Initiated by Firm December 05, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-0232-04
Recall Event ID 27882
Product Classification Monitor, Fetal Doppler Ultrasound - Product Code MAA
Product Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.
Code Information Product is uncoded.
Recalling Firm/
Manufacturer		 Danatech Medical Systems Inc
7275 Nw 68th St Ste 1
Miami FL 33166-3094
For Additional Information Contact Luis F. Guevara
305-883-9716
Manufacturer Reason
for Recall		 This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.
FDA Determined
Cause 2		 Other
Action The firm mailed via overnight priority mail, a recall notification letter with response form to consignees on 12/5/2003 requesting return of the product and refund.
Quantity in Commerce 89 units
Distribution Product was distributed to 89 consumers nationwide.
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.
-
-