Official recall record
IOMAX Cortical Module (ref 75489)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-05-07
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
An assembly error was discovered on the cortical module (PN 190296-200). A cortical module insulator that is used to provide an electric barrier between circuit boards for TCS-9, ICS, and other internal parts was found to be installed incorrectly. The insulator provides clearance between safety critical components and incorrect installation does not meet the minimum creepage/air gap required to meet IEC 60601-1. Recall start date: April 23, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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