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Array Laserlink (2014-04-21)
- Starting date:
- April 21, 2014
- Posting date:
- June 12, 2014
- 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-39983
Recalled products
- Array Laserlink
Reason
In certain limited instances, particularly when the unit is rebooted, the system may project through the slit lamp's oculars an erroneous display which is different than the desired pattern. Although an unlikely occurrence, this represents a potential safety matter. In these rare cases, if the heads-up display does not match the desired pattern, promptly discontinue the treatment and restart the system.
Affected products
A. Array Laserlink
Lot or serial number
- 10072
Model or catalog number
- GA-0006700
Companies
- Manufacturer
-
Lumenis Inc.
3959 West 1820 South
Salt Lake City
84104
Utah
UNITED STATES