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U.S. Department of Health and Human Services

Class 2 Device Recall MiraDry System

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  Class 2 Device Recall MiraDry System see related information
Date Initiated by Firm April 24, 2011
Date Posted June 17, 2011
Recall Status1 Terminated 3 on June 17, 2011
Recall Number Z-2591-2011
Recall Event ID 58853
510(K)Number K103014  
Product Classification Instrument for treatment of hyperhidrosis - Product Code OUB
Product MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece
(MD3001-HP), the miraDry biotip and the miraDry Treatment Template system.
Miramar Labs, Inc.
445 Indio Way
Sunnyvale, CA 94085

Intended use: Treatment of primary axillary hyperhidrosis.
Code Information Serial numbers: 10H0158, 10H0160, 10H0161, 10H0167, 10H0172, 10H0185, 10H0193, 11H0035.
Recalling Firm/
Manufacturer		 Miramar Labs, Inc.
445 Indio Way
Sunnyvale CA 94085-4203
For Additional Information Contact Kathy O'Shaughnessy, PhD.
408-940-8711
Manufacturer Reason
for Recall		 Reports of skin burns on axilla after treatment with the miraDry System.
FDA Determined
Cause 2		 Device Design
Action The firm,Miramar, has a service provider in Japan that assists in dealing with customers. The service providers were provided a copy of the investigation report and communicated directly with the customers to set up appointments for the field correction. The customers were personally visited by a representative from Miramars service provider in Japan. All devices had field correction performed on April 26-28, 2011.
Quantity in Commerce 8 units
Distribution International only: Japan
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 = OUB and Original Applicant = MIRAMAR LABS, INC.
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