Device recall: RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of…
Class II FDA enforcement event 68162. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external…
Class II, in the words of FDA
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
RAYSEARCH LABORATORIES AB started this device recall on 25 Apr 2014. The firm address in the FDA record is in Stockholm. FDA put the recall in Class II. FDA event 68162 has 1 product record. The first FDA enforcement report date is 25 Jun 2014. The record gives the status Terminated, with the termination date 26 Jun 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy,…
Recalling firm
RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1806-2014 | RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. | 25 sites/245 units (US), 25 sites/124 units (foreign) | Class II | Terminated | 25 Jun 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 57
Other events of the firm
Official channels
- FDA enforcement report Z-1806-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 68162. https://recallregister.com/fda/ii/68162/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy,…
- What quantity of product is in FDA event 68162?
- The FDA record gives this quantity:
25 sites/245 units (US), 25 sites/124 units (foreign)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.