Cascade IOMAX Cortical Module (Cadwell) – Circuit Board Defect (2024)
A defective printed circuit board may cause unintended electrical stimulation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Brand
Cadwell Industries Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Cadwell Industries Inc is recalling Cascade IOMAX Cortical Module, REF: 190296-200 due to Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resultin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL
Page updated: Jan 10, 2026