Infinium Medical CLEO Patient Monitor /Tranquility VS Patient Monitor recall — FDA Z-1926-2019
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Overview of recall records associated with Infinium Medical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
This page summarizes recall records in which the official source identifies Infinium Medical, 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.