CLASS II Device recall · Reported 18 Mar 2020 · FDA Enforcement Report
RayStation/RayPlan 8A, Build Number 0.0.61, stand-alone recalled
Raysearch Laboratories Ab is recalling RayStation/RayPlan 8A, Build Number 0.0.61, stand-alone, distributed in Tennessee. The recall was initiated on 20 Feb 2020 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-1462-2020
- FDA event ID
- 85065
- Recalling firm
- Raysearch Laboratories Ab, Stockholm
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2020
- FDA classified
- 10 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 20 Feb 2020 | Recall initiated by company | |
| 10 Mar 2020 | Classified by FDA | +19 days |
| 18 Mar 2020 | 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
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
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/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
Where it was distributed
The products were distributed to the following US states: TN
Questions about this recall
Is RayStation/RayPlan 8A, Build Number 0.0.61, stand-alone recalled?
Yes. Raysearch Laboratories Ab recalled RayStation/RayPlan 8A, Build Number 0.0.61, stand-alone on 20 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1462-2020.
Why was it recalled?
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Which lots are affected?
UDI 07350002010112
Where was it sold?
The products were distributed to the following US states: TN
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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