Hires Ultra Ci Hifocus Ms & Slimj Electrode And Hires Ultra 3d Ci With Hi Focus Ms & Slimj Electrode (2020-02-18)

Recall Summary HiRes Ultra CI and HiRes Ultra 3D cochlear implant devices with HiFocus MS and SlimJ electrodes are being recalled in Canada due to a defect that may cause the implant to stop working. This recall affects cochlear implant systems that were distributed across Canada. The devices are classified as a Class I recall, which indicates a serious safety issue.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-04-17

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/de87903c-e622-43c1-8450-41c5f878171b