Primary source: HSA
HSA Singapore published an urgent field action notification for Advanced Bionics HiRes Ultra / Ultra 3D cochlear implants regarding potential device performance issues.
Affected devices may fail or show reduced performance, potentially impacting patient hearing outcomes and requiring active monitoring or replacement.
Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.
Regulatory Intelligence Lead
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Healthcare providers should notify patients and monitor for any device failure or reduced performance.
Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.
Singapore HSA notified about potential performance issues with Advanced Bionics HiRes Ultra / Ultra 3D cochlear implants. Healthcare providers should inform patients and monitor for device failure or reduced performance.
What changed: HSA Singapore published an urgent field action notification for Advanced Bionics HiRes Ultra / Ultra 3D cochlear implants regarding potential device performance issues.
Why it matters: Affected devices may fail or show reduced performance, potentially impacting patient hearing outcomes and requiring active monitoring or replacement.
Practical implication: Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.
Published from the Firecrawl agent regulatory extraction pipeline.
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