Recall Z-1595-2016— Radiometer America Inc

Name: FDA recall Z-1595-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-18

Class II · Terminated

Class II FDA medical device recall by Radiometer America Inc, initiated 2015-11-18, terminated 2018-03-27. It names one FDA 510(k) clearance: K093154. Product: TCM CombiM Modules 903-111. Reason: Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume..

Recalling firm: Radiometer America Inc
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Terminated: 2018-03-27
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical Aps·cleared 2010-02-05

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

TCM CombiM Modules 903-111

Reason for recall

Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.

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