Nihon Kohden America, Inc.

Due to products being shipped/distributed to customers after the products expiration date had past.

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

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

Medical device non-conformance to electrical safety standard (IEC 60601-1).

The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.

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.

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.

When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.