AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
- Recall Initiated
- September 26, 2023
- Posted
- November 25, 2023
- Recall Number
- Z-0403-2024
- Quantity
- 23 units
Reason for Recall
Affected lots of product may experience technical distortions to a greater extent than expected.
Distribution
US States: FL, MO, OH, WI
Lot / Code Info
UDI-DI: 04260223143298; Serial Numbers: 260446-260468
Root Cause
Process change control
Action Taken
An URGENT: MEDICAL DEVICE RECALL SENTIERO notification letter dated 9/26/23 was sent to customers. Actions to be taken by the User: The technical distortions can influence the specified performance of the device when performing diagnostic DPOAEs at high stimuli. Therefore, PATH MEDICAL chose to voluntarily recall affected products for correction. 1. Immediately identify any affected devices at your location and quarantine them. 2. Please return your affected device(s) to your local distributor or PATH MEDICAL directly (Shipping Address: Landsberger Str. 65, 82110 Germering, Germany) to have your PCB replaced. Upon request, return labels can be provided. 3. If the device(s) have been further distributed to other accounts, please forward this notice to them to inform them of the recall. 4. Report any adverse events to FDA MedWatch: Use the MedWatch Online Reporting Form or call 800-332-1088. Re-Screening of patients screened with a device subject to the recall is not necessary, as regular DPAOE screening would not be done at stimuli as high as they would be affected by the issue. Furthermore, DPOAE-based hearing screening always consists of measurements at multiple frequencies. Therefore, false positive DPOAE detections at a single frequency, which are already considered unlikely, would not necessarily falsify the overall screening result (e.g., pass criterion 3 out of 4). Please be aware that your local competent authority may have been informed of this recall, if required by law. Thank you for your cooperation. In case there are additional questions, please contact us under: Mail: qm@pathme.de Phone: +49 (0)89 80076502