CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report
RaySearch Ray Station Radiation Therapy Treatment Planning recalled
Raysearch Laboratories Ab is recalling RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone, distributed nationwide in the US. The recall was initiated on 14 Feb 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-1481-2014
- FDA event ID
- 67535
- Recalling firm
- Raysearch Laboratories Ab, Stockholm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Feb 2014
- FDA classified
- 21 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 14 Feb 2014 | Recall initiated by company | |
| 21 Apr 2014 | Classified by FDA | +66 days |
| 30 Apr 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
RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
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
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Where it was distributed
Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
Nationwide ArizonaCaliforniaColoradoConnecticutDelawareFloridaIllinoisMassachusettsMarylandMississippiNew JerseyNew YorkOhioPennsylvaniaTennesseeVirginiaWashington
Questions about this recall
Is RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone recalled?
Yes. Raysearch Laboratories Ab recalled RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone on 14 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1481-2014.
Why was it recalled?
RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
Which lots are affected?
Versions: 2.0.0.15, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9.
Where was it sold?
Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
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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