Every recall we track for Nihon Kohden America Inc — 6 in all — plus the complaints and injury reports the public filed about them.
Nihon Kohden recalls adult forehead SpO2 sensors due to lack of FDA approval for U.S. distribution. Affected models include 809030006 with specific lot numbers. Consumers should check their product details.
Nihon Kohden recalls adult ear clip SpO2 sensors without FDA approval for U.S. use. This device may not meet safety standards, but no specific action is required.
Nihon Kohden recalls BSM-3000 Series Bedside Monitors with serial numbers 1613-1651 due to false "SpO2 Probe Failure" alarms. Affected units may display incorrect alerts.
Nihon Kohden recalls expired Adult Cap-ONE Biteblock models YG-227T due to distribution after expiration. These devices may not function safely during endoscopy procedures.
Nihon Kohden recalls specific WMTS Telemetry Receivers due to incorrect date stamps or no data transfer. Affected models include ORG 9100A, 9110A, and 9700A with specific serial numbers. Consumers should check their device details.
Nihon Kohden recalls PSG-1100 Sleep Diagnostic Systems with specific serial numbers due to electrical safety non-conformance with IEC 60601-1 standards. Affected units may pose a risk of electrical shock during sleep studies.
