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

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  Reason
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  Affected products

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