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Health product recall

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

  1. Portable Programming System
  2. Nucleus 24 Auditory Brainstem Implant System
  3. 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