Z-3048-2017 Class II Terminated
FDA device recall Z-3048-2017 was initiated by Solta Medical Inc on June 1, 2017 and is designated Class II. 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. The recall status is terminated (terminated November 30, 2020). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2017
- Initiation Date
- June 1, 2017
- Termination Date
- November 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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.
Distribution Pattern
US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
Code Information
Reference No. 110-0032; Shipping P/N P007014-03; Device P/N P007023-03; Serial No. 001CW9, 000V1W, 000VBK, VAS10-0135-SB, 001FM0, 000TJ5, 00190Q.