Health product recall

Fluence Cartridge (2018-10-01)

Starting date:
October 1, 2018
Posting date:
October 26, 2018
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-68072

Affected products

Fluence Cartridge

Reason

Major deviations since non-qualified critical suppliers of critical parts were used. May not meet the requirements of the regulation.

Affected products

Fluence Cartridge

Lot or serial number

S/N:410501409

Model or catalog number

APL12246

Companies
Manufacturer
Eurofeedback
ZI Petite Montagne Sud 3 rue de l'Aubrac
Lisses
91090
FRANCE