Overview of recall records associated with Nihon Kohden America Inc., including dates, categories and classifications where available.
Classification mix: Class II: 6.
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
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Medical device non-conformance to electrical safety standard (IEC 60601-1).
This page summarizes recall records in which the official source identifies Nihon Kohden America Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
