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