Edan Diagnostics recalls 7 hospital telemetry transmitters (model iT20) sold in the U.S. with an unapproved FDA function. Affected units have specific serial numbers listed. No action is required as the issue is non-functional and not a safety hazard.
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
Edan Diagnostics recalled 7 hospital telemetry transmitters (model iT20) because they included a function not approved by the U.S. FDA. This issue does not pose a safety risk to users and requires no action.
The device includes a function that was not cleared by the U.S. FDA. This means it was not approved for use in hospital environments, but the issue does not cause physical harm or safety risks.
Hospital staff using the Edan iT20 telemetry transmitters in clinical settings like cardiology departments. The risk is minimal as the issue is non-functional and not a safety hazard.
Check if your telemetry transmitter has serial numbers: 260638-M16400850001, 260638-M17211500001, 260638-M17211500002, 260638-M17211500003, 260638-M17211500004, 261350-M17A03030001, or 261350-M17A03030002.
Verify if your device has one of the listed serial numbers: 260638-M16400850001, 260638-M17211500001, 260638-M17211500002, 260638-M17211500003, 260638-M17211500004, 261350-M17A03030001, or 261350-M17A03030002.
No action is required as the issue is non-functional and not a safety hazard.
The device includes a function that was not cleared by the U.S. FDA, but this does not pose a safety risk.
7 units were recalled with specific serial numbers listed in the notice.
We’ve drafted a message you can send Edan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1256-2020 — Edan Diagnostics Edan Diagnostics Hello, I own a Edan Diagnostics that is covered by recall Z-1256-2020 from Edan Diagnostics. 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.
