Z-3048-2017Class II

VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier...

Name: Z-3048-2017 VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier...
Creator: Solta Medical Inc
Published: 2017-06-01
License: https://open.fda.gov/license/

Solta Medical, Inc. / initiated 2017-06-01 / Terminated / root cause: manufacturing process

FDA source

Solta Medical Inc began a recall of 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... on 2017-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3048-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Posted: 2017-08-21
Terminated: 2020-11-30
Recalling firm: Solta Medical, Inc.
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 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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: 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.
Quantity in commerce: 7 units
Distribution: US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3048-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3047-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21
Z-3048-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-21

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)