FDA Device recall Z-1595-2016
TCM CombiM Modules 903-111
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of TCM CombiM Modules 903-111 by Radiometer America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1595-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-18 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Radiometer America |
| Distribution | US |
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.
Identifiers
| code_info | Part Number: 903-111 Lot Number: Below R0174 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Radiometer America
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
FDA Device · Class II · 2019-08-28 · Radiometer America - Product: ABL800 FLEX with Crea
FDA Device · Class II · 2019-02-13 · Radiometer America - ABL800 analyzer, model numbers 393-800 and 393-801
FDA Device · Class II · 2019-01-02 · Radiometer America - ABL90 FLEX analyzers with software versions 3.3MR1 or below
FDA Device · Class II · 2018-10-10 · Radiometer America - ABL800 analyzer with FLEXQ module
FDA Device · Class II · 2017-12-20 · Radiometer America
All Radiometer America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1595-2016%22
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