Z-2349-2024Class II

Cascade IOMAX Cortical Module, REF: 190296-200

Name: Z-2349-2024 Cascade IOMAX Cortical Module, REF: 190296-200
Creator: Cadwell Industries Inc
Published: 2024-05-17
License: https://open.fda.gov/license/

Cadwell Industries Inc / initiated 2024-05-17 / Open, Classified / root cause: manufacturing process

FDA source

Cadwell Industries Inc began a recall of Cascade IOMAX Cortical Module, REF: 190296-200 on 2024-05-17. FDA classified it as Class II and gives the reason as "Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2349-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-17
Posted: 2024-07-12
Recalling firm: Cadwell Industries Inc
Product: Cascade IOMAX Cortical Module, REF: 190296-200
Product code: GWF Stimulator, Electrical, Evoked Response
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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 [email protected]. 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 commerce: 26 units
Distribution: US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2349-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2349-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12

Product code GWF

K162199Class IICascade IOMAX Intraoperative MonitorCadwell Industries, Inc. / cleared 2017-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)