Summary
The FDA issued a Class II for Cascade IOMAX Cortical Module, REF: 190296-200 by Cadwell Industries Inc. Reason: Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resultin.
Details
Source
Device Recall
External ID
Z-2349-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
Cascade IOMAX Cortical Module, REF: 190296-200
Lot/Code Info: UDI: 00840067100653/Serial Numbers:19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004,19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224010, 19029603AA0224021, 19029603AA0224027, 19029603AA0324006, 19029603AA0324007, 19029603AA0324008, 19029603AA0324009, 19029603AA0324010, 19029603AA0424001, 19029603AA0424002, 19029603AA0424003, 19029603AA0424006, 19029603AA0424007, 19029603AA0424008, 19029603AA0424009, 19029603AA0424010, 19029603AA0524003, 19029603AA0524004
Quantity Affected: 26 units
Reason for Recall
Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
Distribution
US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-17
Company
Kennewick, WA
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 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cadwell Industries Inc has 5 FDA actions in our database, including 2 recalls and 3 clearances.
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 (Cadwell Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cadwell Industries Inc have FDA actions?
Cadwell Industries Inc has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2349-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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