Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
Brand(s)
Last updated
Summary
Product
Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
Issue
Medical devices - Performance
What to do
PATH MEDICAL GMBH : FSCA@PATHME.DE
Audience
Healthcare
Industry
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies
Natus Medical Denmark Aps
Hoerskaetten 9, Taastrup, Denmark, 2630
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81684
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