CanadaThe Madsen AccuScreen TEOAE/DPOAE/ABR Probe (model/catalogue number 8-69-41100; affected units include lot/serial numbers consisting of more than 10 numbers — contact the manufacturer for specifics) is affected. It was recalled because there is an inherent risk of a false pass (false negative) with the DPOAE testing protocol that is increased when deviating from the AccuScreen factory default DPOAE Protocol (DP-1) using this probe. Owners should contact PATH MEDICAL GMBH at FSCA@PATHME.DE.
What's being recalled
Companies: Natus Medical Denmark Aps, Hoerskaetten 9, Taastrup, Denmark, 2630.
How to identify it
Affected products: Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8-69-41100
The hazard
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.
What to do
PATH MEDICAL GMBH : FSCA@PATHME.DE
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)