Z-0141-2027

Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code...

Name: Z-0141-2027 Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code...
Creator: Cadwell Industries Inc
Published: 2026-08-18
License: https://open.fda.gov/license/

Cadwell Industries Inc / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-0141-2027
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-10-09
Recalling firm: Cadwell Industries Inc
Product: Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V. Component: Is the cortical component of the IOMAX system
Product code: GWF Stimulator, Electrical, Evoked Response
Reason for recall: Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.
FDA root cause: Under Investigation by firm
Action: On 08/18/2026, an "URGENT: MEDICAL DEVICE RECALL" Letter was emailed informing customers that, a manufacturing defect was identified in a limited number of IOMAX Cortical Modules. Following a recent change in printed circuit board assembly (PCBA) vendor, the defect was discovered during routine production processes on a limited number of PCBA s that were used in IOMAX Cortical Modules. The identified risk is specific to the Cortical Module and Cascade Surgical Studio (CSS). However, because Cortical Modules can be used with Zenith, Arc, and CSS, a module currently in use with Zenith or Arc could later be connected to CSS. Cadwell is therefore recalling all potentially affected Cortical Modules regardless of current host system. If the defective PCBA is present, it could potential cause unintentionally deliver electrical stimulation to the patient, or allow a small amount of unintended electrical current to reach the patient. Customers are instructed to return all identified devices to Cadwell Industries, Inc. Cadwell Industries, Inc. is voluntarily recalling and replacing or repairing all affected devices from the field.
Quantity in commerce: 23
Distribution: Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.
Product codes and lots: Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Lot Code: These devices are identified by the serial numbers listed below: 19029607AA0326007 19029607AA0226013 19029607AA0426028 19029607AA0226010 19029607AA0226007 19029607AA0326026 19029607AA0226015 19029607AA0326020 19029607AA0326018 19029607AA0326021 19029607AA0326022 19029607AA0226009 19029607AA0526022 19029607AA0326017 19029607AA0326027 19029607AA0326016 19029607AA0226016 19029607AA0326028 19029607AA0326024 19029607AA0326025 19029607AA0326023 19029607AA0326031 19029607AA0326006

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)