Urgent Field Action Notification of Advanced Bionics HiRes Ultra/ HiRes Ultra 3D

A Dear Healthcare Professional Letter has been issued by The Listening Lab Pte Ltd to inform healthcare professionals of the recall for unimplanted devices of HiRes Ultra and Ultra 3D cochlear implant devices with Serial Numbers below the 2000000 range as the performance of the implant does not meet manufacturer's standard. Performance issues include drop in impedance and degradation of hearing performance. In a small number of cases, fluid ingress at the electrode can occur leading to interruption of stimulation. The hermetic seal has been shown to be intact. Healthcare professionals are advised not to implant any of the affected devices and to manage patients implanted with the affected devices according to product owner’s recommendations. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

1 Apr 2020

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.