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U.S. Department of Health and Human Services

Class 2 Device Recall IOMAX Cortical Module

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 Class 2 Device Recall IOMAX Cortical Modulesee related information
Date Initiated by FirmMay 17, 2024
Date PostedJuly 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2349-2024
Recall Event ID 94764
510(K)NumberK162199 
Product Classification Stimulator, electrical, evoked response - Product Code GWF
ProductCascade IOMAX Cortical Module, REF: 190296-200
Code Information 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
FEI Number 3020018
Recalling Firm/
Manufacturer		 Cadwell Industries Inc
909 N Kellogg St
Kennewick WA 99336-7669
For Additional Information ContactBecky Corral
509-735-6481
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionOn 5/17/2024, Cadwell Industries, Inc. issued "Urgent: Medical Device Recall" notification to affected consignees via E-Mail. Cadwell ask consignees to take the following actions: 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. Please complete acknowledgement and product replacement form.
Quantity in Commerce26 units
DistributionUS: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GWF
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