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U.S. Department of Health and Human Services

Class 2 Device Recall Lipoplasty

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  Class 2 Device Recall Lipoplasty see related information
Date Initiated by Firm June 01, 2017
Create Date August 21, 2017
Recall Status1 Terminated 3 on November 30, 2020
Recall Number Z-3047-2017
Recall Event ID 77655
510(K)Number K110306  
Product VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA

The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Code Information Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY.
Recalling Firm/
Manufacturer		 Solta Medical Inc
11720 N Creek Pkwy N Ste 100
Bothell WA 98011-8244
Manufacturer Reason
for Recall		 Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
FDA Determined
Cause 2		 Equipment maintenance
Action Consignees were telephoned on June 1, 2017, as initial recall notification. At that time, all consignees agreed to discontinue use of the affected product until it was returned or repaired. An Urgent Medical Device Recall letter dated June 14, 2017, requested that consignees that have not been contacted regarding this recall and have a device repaired between the dates of 09/08/2016 and 05/23/2017 contact Solta Medical immediately at 877-782-2286. Any questions regarding the recall can be directed to Solta Medical Product Support Team at 877-782-2286 or 510-259-5299, option 2.
Quantity in Commerce 4 units
Distribution US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
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 = and Original Applicant = SOUND SURGICAL TECHNOLOGIES LLC.
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