FDA Device recall Z-1930-2013
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com by Radiometer America, citing RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1930-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-27 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Radiometer America |
| Distribution | US |
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.
Identifiers
| code_info | TCM4 series Base Units: 000-154, 391-876, 391-878 and 391-880 below R0175N009 & Power Supply (Spare part): 910-246. Se…TCM4 series Base Units: 000-154, 391-876, 391-878 and 391-880 below R0175N009 & Power Supply (Spare part): 910-246. Serial #: 154R0002N002, 154R0004N003, 154R0004N008, 154R0005N004, 154R0005N005, 154R0005N005-U, 154R0005N006-154R0005N006, 154R0006N005, 154R0006N006, 154R0006N008-154R0006N010, 154R0007N001-154R0007N010, 154R0008N001, 154R0008N002, 154R0008N002U, 154R0008N003, 154R0008N005-154R0008N010, 154R0009N004, 154R0009N010, 154R0011N003, 154R0011N006-154R0011N009, 154R0012N001-154R0012N003, 154R0013N004, 154R0013N005, 154R0013N007-154R0013N010, 154R0014N009, 154R0016N001-154R0016N003, 154R0016N008, 154R0016N009, 154R0016N010, 154R0017N007, 154R0019N001-154R0019N005, 154R0019N007, 154R0019N009, 154R0019N010, 154R0020N002, 154R0021N003, 154R0021N004U, 154R0021N005, 154R0021N008, 154R0021N010, 154R0022N008-154R0022N010, 154R0023N006, 154R0023N007, 154R0023N009, 154R0023N010, 154R0024N004-154R0024N006, 154R0024N009, 154R0024N010, 154R0025N002, 154R0025N004-154R0025N006, 154R0026N008, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1930-2013%22
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