FDA Device recall Z-1882-2024
Cascade IOMAX Cortical Module, REF: 190296-200
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of Cascade IOMAX Cortical Module, REF: 190296-200 by Cadwell Industries, citing there is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1882-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-23 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cadwell Industries |
| Distribution | US |
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Reason
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
Identifiers
| code_info | UDI-DI: 00840067100653/ Serial numbers: 19029603AA1223002 19029603AA1223003 19029603AA1223004 19029603AA1223005 1902960…UDI-DI: 00840067100653/ Serial numbers: 19029603AA1223002 19029603AA1223003 19029603AA1223004 19029603AA1223005 19029603AA1223006 19029603AA1223007 19029603AA1223011 19029603AA1223012 19029603AA1223013 19029603AA1223014 19029603AA1223015 19029603AA1223016 19029603AA1223017 19029603AA1223018 19029603AA1223019 19029603AA1223020 19029603AA1223024 19029603AB1223021 19029603AB1223023 19029603AA1223025 19029603AA0124001 19029603AA0124002 19029603AA0224008 19029603AA0124007 19029603AA0124012 19029603AA0124017 19029603AA0124004 19029603AA0124010 19029603AA0124016 19029603AA0224010 19029603AA0124015 19029603AA1223026 19029603AA0124008 19029603AA0124009 19029603AA1223027 19029603AA1223028 19029603AA1223029 19029603AA0124003 19029603AA0224001 19029603AA1223030 19029603AA1223008 19029603AA1223009 19029603AA0124013 19029603AA1223031 19029603AA1223001 19029603AA0224002 19029603AA0224003 19029603AA0224004 19029603AA0224005 19029603AA0224006 19029603AA0224007 19029603AA0124014 19029603AA0224009 190296 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1882-2024%22
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