HiRes Ultra CI HiFocus MS & SlimJ Electrode and HiRes Ultra 3D CI with Hi Focus MS & SlimJ Electrode (2020-02-18)
- Starting date:
- February 18, 2020
- Posting date:
- April 17, 2020
- 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-72773
Last updated: 2020-04-21
Affected Products
- HiRes Ultra CI HiFocus MS Electrode
- HiRes Ultra CI HiFocus SlimJ Electrode
- HiRes Ultra 3D CI with Hi Focus MS Electrode
- HiRes Ultra 3D CI with HiFocus SlimJ Electrode
Reason
This voluntary field corrective action is being initiated due to a small number of initial HiRes Ultra and HiRes Ultra 3D devices explanted as a result of a performance issue. The defect was discovered during the device failure analysis on an explanted device in March 26, 2019.
Affected products
A. HiRes Ultra CI HiFocus MS Electrode
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CI-1600-04
Companies
- Manufacturer
-
Advanced Bionics AG
Laubisrütistrasse 28
Stäfa
8712
SWITZERLAND
B. HiRes Ultra CI HiFocus SlimJ Electrode
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CI-1600-05
Companies
- Manufacturer
-
Advanced Bionics AG
Laubisrütistrasse 28
Stäfa
8712
SWITZERLAND
C. HiRes Ultra 3D CI with Hi Focus MS Electrode
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CI-1601-04
Companies
- Manufacturer
-
Advanced Bionics AG
Laubisrütistrasse 28
Stäfa
8712
SWITZERLAND
D. HiRes Ultra 3D CI with HiFocus SlimJ Electrode
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CI-1601-05
Companies
- Manufacturer
-
Advanced Bionics AG
Laubisrütistrasse 28
Stäfa
8712
SWITZERLAND