Class 2 Device Recall Sonotrax

• Date Initiated by Firm: December 05, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated 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.
• FEI Number: 1000541224
• 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: 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.