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.
FDA Recall Z-2591-2011 · Posted 2011-06-17
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Recalling FirmMiramar Labs, Inc.
Recall StatusTerminated
Product CodeOUB
Date Initiated2011-04-24
Date Terminated2011-06-17
Product Quantity8 units
Reason for Recall
Reports of skin burns on axilla after treatment with the miraDry System.
Firm 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.
Root Cause
Device Design
Distribution Pattern
International only: Japan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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