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Health product recall

EndyMed Pure System (2017-09-04)

Starting date:
September 4, 2017
Posting date:
September 26, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-64566

Affected products

EndyMed Pure System

Reason

Clarion Medical is voluntarily conducting a recall of the EndyMed Pure System due to an advised error code traced to a potentially faulty main board. The issue results in the handpiece losing contact with the main board when connected to the system resulting in an error which results in the system not functioning.

Affected products

EndyMed Pure System

Lot or serial number

All the serial numbers

Model or catalog number

ND_PRD00231

Companies
Manufacturer
ENDYMED MEDICAL LTD.
12 LESHEM STREET
CAESAREA
3088900
ISRAEL