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Urgent Field Action

publicHSA · Singapore · Updated Jun 4, 2026

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

Urgency: High

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Urgent Field Action
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