Recall Z-3048-2017— Solta Medical Inc
Class II · Terminated
Class II FDA medical device recall by Solta Medical Inc, initiated 2017-06-01, terminated 2020-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, 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).. Reason: 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..
- Recalling firm
- Solta Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-01
- Terminated
- 2020-11-30
- Firm location
- Bothell, WA, United States
Product description
VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, 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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.