Edan recalls iM50, iM60, iM70, iM80 patient monitors due to potential cybersecurity issues. Affected units have serial numbers listed in the recall notice. No remedy specified in official notice.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan is recalling its iM50, iM60, iM70, and iM80 patient monitors because of potential cybersecurity issues identified by the FDA. The recall does not specify a remedy in the official notice.
The recall mentions potential cybersecurity issues identified by the FDA, but the official notice does not describe the specific hazard mechanism or how it could affect users.
Patients using these monitors in healthcare settings are affected. The recall does not specify which specific models or serial numbers are impacted beyond the listed models.
Check if your patient monitor model is iM50, iM60, iM70, or iM80. Look for the serial numbers listed in the recall notice (e.g., 002327-M16803350001, 333109-M16203920001, etc.).
Identify if your patient monitor is an iM50, iM60, iM70, or iM80 model.
The official recall notice states there is a potential cybersecurity issue identified by the FDA, but does not specify the exact risk or how it could affect users.
The official recall notice does not specify any remedy or action steps for affected units.
Check if your monitor model is iM50, iM60, iM70, or iM80, and verify the serial number against the list provided in the recall notice.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1145-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1145-2026 from Edan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
