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.
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 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
Related recalls
Same manufacturer · Nihon Kohden America Inc
See all →- ModerateAdult Cap-ONE Biteblock devices recalled for expired product distribution
FDA (Devices) · 2024-11-13
- HighNihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval
FDA (Devices) · 2024-11-06
- HighNihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
FDA (Devices) · 2024-11-06
- HighBedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms
FDA (Devices) · 2024-06-12
- ModerateNihon Kohden PSG-1100 Sleep Diagnostic System Recalled for Electrical Safety Non-Conformance
FDA (Devices) · 2021-02-03
Same hazard · data integrity
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- SevereCopan WASPLab Software Recall Over Results Overwrite Issue
FDA (Devices) · 2026-08-12
- SevereGE Healthcare MAC VU360 Electrocardiograph Software Recall
FDA (Devices) · 2026-08-12
- SevereMedline spinal block trays recalled over Huons bupivacaine quality concerns
FDA (Devices) · 2026-06-03
- SevereMedline pain and Whitacre spinal trays recalled over bupivacaine concerns
FDA (Devices) · 2026-06-03