CLASS II Device recall · Reported 25 Jun 2014 · FDA Enforcement Report
RayStation software version 4.0.3.4 RayStation is a software system recalled
Raysearch Laboratories Ab is recalling RayStation software version 4.0.3.4 RayStation is a software system, distributed nationwide in the US. The recall was initiated on 25 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1806-2014
- FDA event ID
- 68162
- Recalling firm
- Raysearch Laboratories Ab, Stockholm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2014
- FDA classified
- 16 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 25 Apr 2014 | Recall initiated by company | |
| 16 Jun 2014 | Classified by FDA | +52 days |
| 25 Jun 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Where it was distributed
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
Nationwide ArizonaCaliforniaFloridaIllinoisMassachusettsMarylandMissouriMississippiNew JerseyNevadaNew YorkOhioPennsylvaniaTennesseeVirginiaWashington
Questions about this recall
Is RayStation software version 4.0.3.4 RayStation is a software system recalled?
Yes. Raysearch Laboratories Ab recalled RayStation software version 4.0.3.4 RayStation is a software system on 25 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1806-2014.
Why was it recalled?
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Which lots are affected?
Software version 4.0.3.4
Where was it sold?
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | RayCare 2024A SP4 recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Other | Nationwide |
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| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction | |
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