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).
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Solta Medical Inc
- UPC
- Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY.
Units Affected
4 units