diVa hand piece (2019-04-06)

Starting date:
April 6, 2019
Posting date:
April 12, 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-69576

Last updated:

Affected Products

diVa hand piece

Reason

Product labelling was updated to include additional indication for use upon Health Canada's approval for the new indication for use.  This indication for use being for the treatment of symptoms of Genitourinary Syndrome of menopause (GSM).

Affected products

diVa hand piece

Lot or serial number

Not applicable.

Model or catalog number

1500-520-00

Companies
Manufacturer
Sciton, Inc.
925 Commercial Street
Palo Alto
94303
California
UNITED STATES