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).
Reported: August 30, 2017 Initiated: June 1, 2017 #Z-3047-2017
Product Description
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).
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.
Details
- Recalling Firm
- Solta Medical Inc
- Units Affected
- 4 units
- Distribution
- US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
- Location
- Bothell, WA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Solta Medical Inc. Units affected: 4 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2017. Severity: Moderate. Recall number: Z-3047-2017.
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