Food, drugs, devices › RAYSEARCH LABORATORIES AB
Device recall: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) a
RAYSEARCH LABORATORIES AB (Stockholm, N/A) initiated this device recall on 20 Nov 2017; FDA lists 1 product record under event 83152, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 8 Aug 2023. Initiation: voluntary: firm initiated. RAYSEARCH LABORATORIES AB has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden.
Reason for recall
"When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong"
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1930-2019 | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy | 744 | Class II | Terminated | 10 Jul 2019 |
Context
Other enforcement events for RAYSEARCH LABORATORIES AB
All 57 events for RAYSEARCH LABORATORIES AB
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Aug 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.