FDA Device recall Z-0456-2014
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
- FDA Device
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological by Iba Dosimetry, citing the development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Un….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0456-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-20 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iba Dosimetry |
| Distribution | CA, CT, MA, NY, OH, OK, SC |
Product
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Reason
The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.
Identifiers
| code_info | SW Version 3.0. Catalong Number CS10-100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Iba Dosimetry
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FDA Device · Class II · 2025-05-07 · Iba Dosimetry - Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Device · Class II · 2017-06-14 · Iba Dosimetry - IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
FDA Device · Class II · 2016-01-27 · Iba Dosimetry - COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
FDA Device · Class II · 2015-03-04 · Iba Dosimetry - COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA Device · Class II · 2014-11-12 · Iba Dosimetry
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0456-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.