FDA Device recall Z-1155-2026
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters…
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters… by Edan Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1155-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-24 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Edan Diagnostics |
| Distribution | US |
Product
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No
Reason
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.
Identifiers
| code_info | EDAN Model: iT20 UDI-DI code: 06944413802261 Serial/Lot Numbers: 261350-M17A03030002 261350-M17A03030001 260881-M184073…EDAN Model: iT20 UDI-DI code: 06944413802261 Serial/Lot Numbers: 261350-M17A03030002 261350-M17A03030001 260881-M18407300001 260881-M18407300002 260881-M18407310002 260881-M18407310001 260881-M18703320002 260881-M18703320004 260881-M18703320001 260881-M18703320003 260881-M18800890008 260881-M18800890003 260881-M18800890004 260881-M18800890005 260881-M18800890007 260881-M18800890001 260881-M18800890006 260881-M18800890002 260881-M18800890010 260881-M18810400010 260881-M18810400009 260881-M18810400008 260881-M18810400004 260881-M18810400003 260881-M18810410008 260881-M18810410006 260881-M18810410002 260881-M18810400007 260881-M18810400002 260881-M18810400001 260881-M18810410003 260881-M18810410007 260881-M18810410001 260881-M18810410010 260881-M18810410005 260881-M18810410009 260881-M18810410004 260881-M18810400005 260881-M18810400006 260881-M18901010006 260881-M18901000007 260881-M18901000009 260881-M18901000012 260881-M18901000017 260881-M18901000018 260881-M18901000002 260881-M1890101 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1155-2026%22
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