Iba Dosimetry Gmbh
Medical device manufacturer in Schwarzenbruck, Germ.
3510(k) clearances
0PMA approvals
6recalls
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1703-2025 Class II | myQA iON; Article Number: MQ10-000;Wrong analysis results can occur if the user creates two structures with the same name, except for one… | 04/01/2025Open, Classified |
| Z-2220-2017 Class II | Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T…When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured… | 04/26/2017Terminated |
| Z-0683-2016 Class II | IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2When the electric lift table is connected to the mains power, in a very rare occasion, the table may start… | 12/10/2015Terminated |
| Z-1212-2015 Class II | COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiologicalError in the software. During internal tests of the current development version of the Compass SW it was… | 02/02/2015Terminated |
| Z-0168-2015 Class II | COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear…Error in the software. A deviation between reconstructed and planned dose distribution may not be detected… | 09/25/2014Terminated |
| Z-0456-2014 Class II | iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator)…The development partner of IBA informed that there is problem in a SW component used in COMPASS when… | 08/20/2013Terminated |