Device recall: The product affected by this notice is sold under the trade name “TomoTherapy SharePlan 1.1”. To determine if the…
Class II FDA enforcement event 63110. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere
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 30 May 2011. The firm address in the FDA record is in Stockholm. FDA put the recall in Class II. FDA event 63110 has 1 product record. The first FDA enforcement report date is 26 Sep 2012. The record gives the status Terminated, with the termination date 16 Nov 2012.
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 including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
Recalling firm
RAYSEARCH LABORATORIES AB, Stockholm, 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-2378-2012 | The product affected by this notice is sold under the trade name “TomoTherapy SharePlan 1.1”. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is “1.3.1.10”. Intended use: t-RayAutoplan is a software that, based on… | 15 units | Class II | Terminated | 26 Sep 2012 |
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 2011
- 114
- Share of these events in Class II
- 89%
- 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-2378-2012The 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 63110. https://recallregister.com/fda/ii/63110/. 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 including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
- What quantity of product is in FDA event 63110?
- The FDA record gives this quantity:
15 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2011 have the same class?
- 89% of the 114 device events that started in 2011 are in Class II.