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Vaser Amplifier
- Starting date:
- June 15, 2017
- Posting date:
- July 7, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63860
Reason
Solta Medical is conducting a voluntary recall of the Vaser Amplifier that were returned to the Solta Bothell Washington service depot for repair between September 8, 2016 and May 23, 2017 due to the potential that the device was inaccurately tuned by the service depot during repair. The use of the product in the affected range constitutes a potential risk and could contribute to burns.
Affected products
Vaser Amplifier
Lot or serial number
SN 000V9Z
SN 0019XJ
Model or catalog number
110-0032
Companies
- Manufacturer
-
Solta Medical Inc.
11720 North Creek Parkway N, Suite 100
Bothell
98011
Washington
UNITED STATES