Recall Z-2591-2011 ยท OUB Instrument For Treatment Of Hyperhidrosis
Miramar Labs, Inc.
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.
| Date | Jun 17, 2011 (initiated Apr 24, 2011) |
| Status | Terminated |
| Reason | Reports of skin burns on axilla after treatment with the miraDry System. |
| Root cause | 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 | 8 units |
| Distribution | International only: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103014 | MIRADRY SYSTEM Miramar Labs, Inc., Jan 28, 2011 |