MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Trea
FDA device recall Z-2591-2011 · posted 2011-06-17 · Terminated
Recall details
- Recalling firm
- Miramar Labs, Inc.
- Reason for recall
- Reports of skin burns on axilla after treatment with the miraDry System.
- Action taken
- 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
- Status
- Terminated
- Product code
- OUB
- Quantity affected
- 8 units
- Distribution
- International only: Japan
- Date initiated
- 2011-04-24
- Date posted
- 2011-06-17
- Date terminated
- 2011-06-17
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MIRADRY SYSTEM (K103014) | Miramar Labs, Inc. | 2011-01-28 |