This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Lythos Digital Impression System (2013-11-25)
- Starting date:
- November 25, 2013
- Posting date:
- February 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37553
Recalled Products
Lythos Digital Impression System
Reason
Certain parameters within the software may prevent system from properly interpreting the images captured, causing the need to re-scan patient's arch.
Affected products
Lythos Digital Impression System
Lot or serial number
DIS13A013N
Model or catalog number
249-4000
Companies
- Manufacturer
-
Ormco Corporation
1332 South Lone Hill Avenue
Glendora
91740
California
UNITED STATES