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Portable Programming System, Nucleus 24 Auditory Brainstem Implant System and Nucleus 24 Channel Cochlear Implant System (2014-06-19)
- Starting date:
- June 19, 2014
- Posting date:
- July 15, 2014
- 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-40449
Recalled products
- Portable Programming System
- Nucleus 24 Auditory Brainstem Implant System
- Nucleus 24 Channel Cochlear Implant System - Double Array
Reason
Device was placed on the market subsequent to expiration of the CE certificate. There is no effect on the safety or performance of the device.
Affected products
A. Portable Programming System
Lot or serial number
No lot numbers
Model or catalog number
- Z42001
Companies
- Manufacturer
-
Cochlear Limited
1 University Avenue, Macquarie University
Macquarie Park, New South Wales
2109
AUSTRALIA
B. Nucleus 24 Auditory Brainstem Implant System
Lot or serial number
No lot numbers
Model or catalog number
- Z43004
Companies
- Manufacturer
-
Cochlear Limited
1 University Avenue, Macquarie University
Macquarie Park, New South Wales
2109
AUSTRALIA
C. Nucleus 24 Channel Cochlear Implant System - Double Array
Lot or serial number
- 5004
- 5006
- 5695
- 5009
- 5010
Model or catalog number
- Z99012
Companies
- Manufacturer
-
Cochlear Limited
1 University Avenue, Macquarie University
Macquarie Park, New South Wales
2109
AUSTRALIA