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.
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510(K) Database | 510(K)s with Product Code = OUB
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