AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Summary
The FDA issued a Class II for AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH10009 by PATH. Reason: Affected lots of product may experience technical distortions to a greater extent than expected..
Details
Source
Device Recall
External ID
Z-0403-2024
Action Date
2023-12-06
Status
Ongoing
Category
device
Product Description
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Lot/Code Info: UDI-DI: 04260223143298; Serial Numbers: 260446-260468
Quantity Affected: 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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-26
Company
Germering
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PATH has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PATH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PATH have FDA actions?
PATH has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0403-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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