Nihon Kohden Telemetry Recalled for Incorrect Date Stamp or No Data Transfer
Nihon Kohden America Inc is recalling WMTS Telemetry Receivers because they may display incorrect date stamps or fail to transfer data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hospitalizations, injuries, or deaths. The hazard involves data integrity issues (incorrect date stamps or no data transfer) rather than direct physical harm, fitting the criteria for a moderate severity recall.
Plain-English summary
Nihon Kohden America Inc is recalling 4,436 units of WMTS Telemetry Receivers, Multiple Patient Receiver, Models ORG 9100A, ORG 9110A, and ORG 9700A. The recall is due to a defect where the devices may display an incorrect date stamp or fail to transfer data.
The affected devices were distributed to facilities in 45 states and the District of Columbia. The recall covers specific serial number ranges for each model: ORG 9100A (00001 to 01413), ORG 9110A (00001 to 02706), and ORG 9700A (00001 to 00894).
Healthcare facilities should contact Nihon Kohden America Inc for instructions on how to resolve the issue with the affected telemetry receivers.
The recalled product
- Product
- WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
- Manufacturer
- Nihon Kohden America Inc
- Category
- Medical Device — Telemetry
- Affected units
- 4,436
Distribution
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