Due to products being shipped/distributed to customers after the products expiration date had past.
Nihon Kohden America
10 recalls • • Categories: Other Medical Devices, Diagnostic Equipment, Infusion Pumps
Class I - Dangerous
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Class I - Dangerous
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Class I - Dangerous
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Class I - Dangerous
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Class I - Dangerous
The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Class I - Dangerous
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.