FDA Devices recall · Reported March 4, 2015
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
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 …
Iba Dosimetry Gmbh recalled COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological - a moderate-severity action.
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological was recalled by Iba Dosimetry Gmbh in March 4, 2015. Reason: Error in the software. During internal tests of the current development version of the Compass SW it was fo…. Check the official notice for the remedy. Verify recall #Z-1212-2015 with the FDA Devices before acting.
The recall
Iba Dosimetry Gmbh issued this moderate-severity FDA Devices recall-Error in the software. During internal tests of the current development version of the Compass SW it was fo….
- Moderate
- severity level
- 124 units
- affected scope
- Class II
- classification
- March 4, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1212-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1212-2015) was formally reported on March 4, 2015, with the manufacturer initiating the action on February 2, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Iba Dosimetry Gmbh is listed as the recalling firm, operating out of Schwarzenbruck, N/A. Federal records list the affected scope as 124 units.
The documented reason for this recall is: 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 b… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and Sou…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1212-2015 |
| Date reported | March 4, 2015 |
| Date initiated | February 2, 2015 |
| Recalling firm | Iba Dosimetry Gmbh |
| Firm location | Schwarzenbruck, N/A |
| Affected scope | 124 units |
| Distribution | Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1212-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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