Recall Z-1926-2019— Infinium Medical, Inc

Name: FDA recall Z-1926-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-31

Class II · Ongoing

Class II FDA medical device recall by Infinium Medical, Inc, initiated 2019-05-31. It names one FDA 510(k) clearance: K142244. Product: CLEO Patient Monitor /Tranquility VS Patient Monitor. Reason: The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option..

Recalling firm: Infinium Medical, Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-05-31
Firm location: Largo, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K142244 — CLEO PATIENT MONITORInfinium Medical·cleared 2015-02-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.