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Infinium Medical, Inc recalls CLEO Patient Monitor /Tranquility VS Patient Monitor
Recalled July 10, 2019 · FDA recall Z-1926-2019 · Infinium Medical
Hazard
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option. · FDA Class II
Units
95 devices
Sold at
Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.
Description
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Product
CLEO Patient Monitor /Tranquility VS Patient Monitor
Manufacturer(s)
Infinium Medical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →