CLASS II Device recall · Reported 1 Apr 2015 · FDA Enforcement Report
RayStation Radiation Therapy Treatment Planning System recalled
Raysearch Laboratories AB is recalling RayStation Radiation Therapy Treatment Planning System, distributed nationwide in the US. The recall was initiated on 4 Mar 2015 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-1310-2015
- FDA event ID
- 70686
- Recalling firm
- Raysearch Laboratories AB, Stockholm
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2015
- FDA classified
- 20 Mar 2015
- Reported
- 1 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 4 Mar 2015 | Recall initiated by company | |
| 20 Mar 2015 | Classified by FDA | +16 days |
| 1 Apr 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
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 Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
Which lots are affected?
Build numbers 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14 and 4.7.0.15
Where was it sold?
Nationwide Distribution.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Raysearch Laboratories AB
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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 | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Device Malfunction |
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