CLASS II Device recall · Reported 1 Aug 2018 · 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 6 Jun 2018 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-2554-2018
- FDA event ID
- 80515
- Recalling firm
- Raysearch Laboratories AB, Stockholm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2018
- FDA classified
- 26 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 6 Jun 2018 | Recall initiated by company | |
| 26 Jul 2018 | Classified by FDA | +50 days |
| 1 Aug 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.
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, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.
Which lots are affected?
2.5.1.89 , 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 4.0.2.9 , 4.0.3.4 , 4.3.0.14 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35, 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19 .
Where was it sold?
US 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
All 115| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | RayCare 2024A SP4 recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Other | Nationwide |
| Device | CLASS II | RayCare 2024A SP1 recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Other | Nationwide |
| 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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