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Supplies for COMBI *M 82
Radiometer Basel AG · Model 0605200 · UDI-DI 05700693095202
10
510(k) clearances
16
Adverse events (3 deaths)
3
Recalls
18
Facilities
Description
Supplies for COMBI *M 82, b0605200ox with 12 pcs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-04-07 | Radiometer America Inc | System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further. |
| 2005-11-01 | Radiometer America Inc | Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations |
| 2005-02-02 | Radiometer America Inc | Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.