FDA Device recall Z-0168-2015
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological by Iba Dosimetry, citing error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0168-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-25 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iba Dosimetry |
| Distribution | n/a |
Product
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Reason
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
Identifiers
| code_info | N/A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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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 - iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA Device · Class II · 2013-12-18 · Iba Dosimetry
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0168-2015%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.