Recall Z-0402-2024 ยท EWO Audiometer
PATH
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
| Date | Nov 25, 2023 (initiated Sep 26, 2023) |
| Status | Open, Classified |
| Reason | Affected lots of product may experience technical distortions to a greater extent than expected. |
| Root cause | 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 y |
| Quantity | 28 units |
| Distribution | US States: FL, MO, OH, WI |
| FDA record | Open on fda.gov |