FDA recall Z-1926-2019

Infinium Medical, Inc · Class II · device

Product

CLEO Patient Monitor /Tranquility VS Patient Monitor

Reason for recall

The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

Distribution

Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.

Key facts

Status
Ongoing
Initiation date
2019-05-31
Report date
2019-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2019