Recall Z-1930-2013— Radiometer America Inc

Name: FDA recall Z-1930-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-27

Class II · Terminated

Class II FDA medical device recall by Radiometer America Inc, initiated 2012-11-27, terminated 2014-06-16. It names 2 FDA 510(k) clearances: K043003, K001866. Product: TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.. Reason: RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B..

Recalling firm: Radiometer America Inc
Classification: Class II
Status: Terminated
Initiated: 2012-11-27
Terminated: 2014-06-16
Firm location: Westlake, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K043003 — TCM40 MONITORING SYSTEMRadiometer Medical Aps·cleared 2005-03-01
K001866 — TCM400Radiometer Medical A/S·cleared 2000-12-07

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

TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.

Reason for recall

RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

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