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
USBrand 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
Recalling Firm: Edan Diagnostics
Reason for Recall / Hazard
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.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 97879 |
| Address 1 | 9833 Pacific Heights Blvd |
| Code info | 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... [TRUNCATED] |
| Postal code | 92121-4707 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 1457 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251024 |
| Initial firm notification | Letter |
| Center classification date | 20260122 |
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Overview
- Recalling FirmEdan Diagnostics
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
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🚨 SAFETY ALERT: Edan Diagnostics - 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 Check if your household is affected: https://therecallfile.com/recalls/brand-name-edan-product-name-telemetry-transmitter-model-catalog-numbe/FDA-Z-1155-2026
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