CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report
RayStation Product Usage: is a software system designed recalled
Raysearch Laboratories Ab is recalling RayStation Product Usage: is a software system designed for treatment, distributed nationwide in the US. The recall was initiated on 17 Jul 2017 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-0380-2018
- FDA event ID
- 78900
- Recalling firm
- Raysearch Laboratories Ab, Stockholm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2017
- FDA classified
- 16 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 17 Jul 2017 | Recall initiated by company | |
| 16 Jan 2018 | Classified by FDA | +183 days |
| 24 Jan 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
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 Product Usage: 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.
Where it was distributed
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
Nationwide ArizonaFloridaMarylandMichiganTennesseeTexasWashington
Questions about this recall
Is RayStation Product Usage: is a software system designed for treatment recalled?
Yes. Raysearch Laboratories Ab recalled RayStation Product Usage: is a software system designed for treatment on 17 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0380-2018.
Why was it recalled?
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Which lots are affected?
6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7
Where was it sold?
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
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.
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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| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |