Health product recall

Nucleus 7 Processing Unit

Brand(s)
Last updated

Summary

Product
Nucleus 7 Processing Unit
Issue
Medical devices - Performance issue
What to do

Acknowledge receipt of notice, contact Cochlear rep to manage recalled units and arrange replacement. 

Affected products

Affected products Lot or serial number Model or catalog number
Nucleus 7 Processing Unit More than 10 numbers, contact manufacturer. Z482008 P732105 Z482007 P732095 P732099 Z482005 Z482006 Z544559 Z482009 P732093 P732101

Issue

This failure mode has potential to manifest for all devices manufactured with apple MFi keys in the range 6100 to 6103 when attempted to pair with iOS devices. Complaints to date have come from CAM, APAC and EMEA regions. This issue is isolated to cp1000 and cp1001 devices manufactured between 1st April to 19th May 2022 when used with any device using Apple iOS.

Recall start date: June 3, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies

Cochlear Limited

1 University Avenue, Macquarie Park, New South Wales, Australia, 2109

Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type III
Identification number
RA-64253

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe