Recall MonitorHealth Products
Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Ear, nose and throat
Product: Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
Issue: Medical devices - Performance
What to do: PATH MEDICAL GMBH : FSCA@PATHME.DE
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe | More than 10 numbers, contact manufacturer. | 8-69-41100 |
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.