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Open, Classified

Cascade IOMAX Cortical Module, REF: 190296-200

FDA Recall Z-2349-2024 · Posted 2024-07-12

Recalling FirmCadwell Industries Inc
Recall StatusOpen, Classified
Product CodeGWF
Date Initiated2024-05-17
Product Quantity26 units

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017-03-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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