FDAFDA · Food and drugs·Recall number Z-3047-2017
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).
Published August 30, 2017 · Recall initiated: June 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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 to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Solta Medical Inc
- Distributor
- US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
- Lot
- Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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