The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2378-2012·Announced 2012-09-26

RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors

RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device software where specific user actions are required to ensure clinical outcomes, representing a risk of harm where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB has issued a field notice for the TomoTherapy SharePlan 1.1 software, also known as t-RayAutoplan version 1.2.1 (build number 1.3.1.10). The notice addresses two specific behaviors of the software, involving Multiple Fraction Groups and Depth Offset, that may be unexpected to users and are not clearly described in the user manual.

The agency classifies this as a Class II recall. According to the source text, none of these behaviors have caused patient mistreatment or other incidents. However, the notice states that specific user actions must be adhered to for the best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment.

The affected software was distributed worldwide, including in the United States (California, Kentucky, Michigan, New York, Oklahoma, and Oregon) and internationally to Canada, Belgium, the United Kingdom, Australia, France, Germany, and Poland. A total of 15 units are affected. Users should check the About box in the SharePlan application to verify if the build number is 1.3.1.10.

The recalled product

Product
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…
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Software
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • SharePlan 1.1
  • aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).

Distribution

Distributed in 6 states:

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