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U.S. Department of Health and Human Services

Class 2 Device Recall Cascade IOMAX Cortical Module

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  Class 2 Device Recall Cascade IOMAX Cortical Module see related information
Date Initiated by Firm April 23, 2024
Date Posted May 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1882-2024
Recall Event ID 94504
510(K)Number K162199  
Product Classification Stimulator, electrical, evoked response - Product Code GWF
Product Cascade IOMAX Cortical Module, REF: 190296-200
Code Information UDI-DI: 00840067100653/ Serial numbers: 19029603AA1223002 19029603AA1223003 19029603AA1223004 19029603AA1223005 19029603AA1223006 19029603AA1223007 19029603AA1223011 19029603AA1223012 19029603AA1223013 19029603AA1223014 19029603AA1223015 19029603AA1223016 19029603AA1223017 19029603AA1223018 19029603AA1223019 19029603AA1223020 19029603AA1223024 19029603AB1223021 19029603AB1223023 19029603AA1223025 19029603AA0124001 19029603AA0124002 19029603AA0224008 19029603AA0124007 19029603AA0124012 19029603AA0124017 19029603AA0124004 19029603AA0124010 19029603AA0124016 19029603AA0224010 19029603AA0124015 19029603AA1223026 19029603AA0124008 19029603AA0124009 19029603AA1223027 19029603AA1223028 19029603AA1223029 19029603AA0124003 19029603AA0224001 19029603AA1223030 19029603AA1223008 19029603AA1223009 19029603AA0124013 19029603AA1223031 19029603AA1223001 19029603AA0224002 19029603AA0224003 19029603AA0224004 19029603AA0224005 19029603AA0224006 19029603AA0224007 19029603AA0124014 19029603AA0224009 19029603AA0124011
Recalling Firm/
Manufacturer		 Cadwell Industries Inc
909 N Kellogg St
Kennewick WA 99336-7669
For Additional Information Contact Jason Ford
509-735-6481
Manufacturer Reason
for Recall		 There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
FDA Determined
Cause 2		 Process design
Action On 4/22/24, Cadwell Industries, Inc. issued a "Urgent: Medical Device Recall" notification to affected consignees via Email: 1. Cease use of the device immediately and return all identified devices to Cadwell Industries, Inc. 2. Please complete the attached response form and return via email to quality@cadwell.com. 3. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred the IOMAX Cortical Module to. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce 54 units
Distribution Worldwide - US Nationwide distribution in the state of MD and the countries of Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, European Union, Switzerland, South Africa, Iraq, United Kingdom.
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 = GWF and Original Applicant = CADWELL INDUSTRIES, INC.
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