Edan iT20 Telemetry Transmitter Recalled for Uncleared Function
Edan Diagnostics is recalling 7 iT20 telemetry transmitters because they include a function not cleared by the U.S. FDA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue (uncleared function) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Edan Diagnostics is recalling 7 units of the EDAN Telemetry Transmitter, Model iT20. The firm identified that these specific units were distributed in the United States with a function that has not been cleared by the U.S. Food and Drug Administration.
The affected devices are intended for use in clinical divisions of hospital environments, including coronary care units (CCU) and general wards. The recall covers 7 units distributed nationwide, specifically within the state of California. The specific serial numbers for the affected units are 260638-M16400850001, 260638-M17211500001, 260638-M17211500002, 260638-M17211500003, 260638-M17211500004, 261350-M17A03030001, and 261350-M17A03030002.
Healthcare facilities should check their inventory for these specific serial numbers. If an affected unit is found, it should be removed from service and returned to Edan Diagnostics for further instructions.
The recalled product
- Product
- EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
- Manufacturer
- Edan Diagnostics
- Affected units
- 7
Distribution
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