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: 2019-04-12
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