Health product recall

Femilift/Pixel CO2 Laser System with Femilift Handpiece (AACO17111361) (2019-02-03)

Starting date:
February 3, 2019
Posting date:
February 15, 2019
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-69042

Affected Products

Femilift/Pixel CO2 Laser System with Femilift Handpiece (AACO17111361)

Reason

Alma Lasers Ltd., is informing customers that it was recently notified by Health Canada that it does not consider the FemiLift / Pixel CO2 laser system and its associated FemiLift handpiece aaco17111361, to be approved for "vaginal rejuvenation" in the Canadian market.

Affected products

Femilift/Pixel CO2 Laser System with Femilift Handpiece (AACO17111361)

Lot or serial number

All Lots.

Model or catalog number

AACO17111361

Companies
Manufacturer
Alma Lasers Ltd.
14 Halamish Street. Caesarea Industrial Park
Caesarea
ISRAEL