Back to RecallTracker
Health Canada Medical devices

Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe

Issued March 4, 2026
Issue
There is already an inherent risk of a false pass with the DPOAE testing protocol with AccuScreen® for a child with a hearing disorder and this cannot be eliminated. This inherent risk of false negative answers was increased when deviating from the AccuScreen® factory default DPAOE Protocol (DP-1) using DPOAE Probe 8-69-41100.
Hazard description
Performance
Product
Product name
Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
Reference
ID
RA-81684