[Recalled] RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system — There is a potential for erroneous propagation of the current tabletop position… | FDA 2020-02-20
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system |
|---|---|
| Brand / manufacturer | RAYSEARCH LABORATORIES AB |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1464-2020 |
| Country of notice | Sweden |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 February 2020 |
| EAN / barcode | 07350002010129 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in Sweden and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from RAYSEARCH LABORATORIES AB
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.