Product Wiki · Recalls · Health Canada — Medical Devices

HiRes Ultra CI HiFocus MS & SlimJ Electrode and HiRes Ultra 3D CI… — recall 63307

Health Canada — Medical Devices · Canada · 2020-04-17 · Type II

As described by Health Canada — Medical Devices: HiRes Ultra CI HiFocus MS & SlimJ Electrode and HiRes Ultra 3D CI with Hi Focus MS & SlimJ Electrode (2020-02-18)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
63307
Date of alert
2020-04-17
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hires-ultra-ci-hifocus-ms-slim

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