Recall record at a glance
| Official record | Z-0732-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Report date | Mar 16, 2022 |
| Recall initiation date | Dec 30, 2021 |
| Quantity | 75 Licenses |
| Location | Stockholm, N/A, Sweden |
Official product description
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build number) UDI-DI RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297
Why the product was recalled
If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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