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U.S. Department of Health and Human Services

Class 2 Device Recall SENTIERO Screening2

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  Class 2 Device Recall SENTIERO Screening2 see related information
Date Initiated by Firm September 26, 2023
Date Posted November 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-0402-2024
Recall Event ID 93275
510(K)Number K133012  K213345  
Product Classification Audiometer - Product Code EWO
Product SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Code Information UDI-DI: 04260223145377; Serial Numbers: 290402-290403, 290405-290408, 290422-290433, 290435-290443, 290446
Recalling Firm/
Manufacturer		 PATH
Landsberger Str. 65
Germering Germany
For Additional Information Contact Diane Sabo, PhD
+498980076502
Manufacturer Reason
for Recall		 Affected lots of product may experience technical distortions to a greater extent than expected.
FDA Determined
Cause 2		 Process change control
Action 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
Quantity in Commerce 28 units
Distribution US States: FL, MO, OH, WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EWO and Original Applicant = PATH MEDICAL GMBH
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