FDA Device recall Z-1212-2015
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological by Iba Dosimetry, citing error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1212-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-02 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iba Dosimetry |
| Distribution | AZ, OK |
Product
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Reason
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
Identifiers
| code_info | Model : SW Version 3.1 Lot or Serial Number : n.a |
|---|
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, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA Device · Class II · 2014-11-12 · 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-1212-2015%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.