This page has been archived on the Web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.
Star S4 LR Excimer Laser System (2013-09-18)
- Starting date:
- September 18, 2013
- Posting date:
- October 28, 2013
- 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-36445
Recalled Products
Star S4 LR Excimer Laser System
Reason
The advisory notice is associated with the VISX Excimer laser system (Licence 2145). This action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure in the ac power distribution printed circuit board (PCB) in the VISX Excimer laser system, specifically models Star S2, Star S3, Star S4 Custom VSS and Star S4 IR.
Affected products
Star S4 LR Excimer Laser System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- STAR S4 IR
Companies
- Manufacturer
-
Amo Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas
95035
California
UNITED STATES