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ELLEX INTEGRA PRO LP5532 (2016-03-16)
- Starting date:
- March 6, 2016
- Posting date:
- April 4, 2016
- 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-57758
Affected Products
ELLEX INTEGRA PRO LP5532
Reason
Under certain conditions there is a potential for the glass of the safety filter optics to crack on their lower edge due to pressure applied on them by their retaining plate which in turn could damage the laser safety coating on the optics. If this occurs, there is a remote possibility the user could be exposed to any diffused reflected laser light during laser treatment.
Affected products
ELLEX INTEGRA PRO LP5532
Lot or serial number
SN # 5A2058
SN # 5A2067
Model or catalog number
LP5532
Companies
- Manufacturer
-
ELLEX MEDICAL PTY LTD
82 GILBERT STREET
ADELAIDE
5000
AUSTRALIA