Recall archive
53 recalls · page 3 of 3
Reported Nov 20, 2013
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand · Reason for recall — Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when…
FDA (openFDA device enforcement)
Reported Jun 5, 2013
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be…
FDA (openFDA device enforcement)
Reported Oct 3, 2012
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused…
FDA (openFDA device enforcement)
Reported Sep 26, 2012
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly…
FDA (openFDA device enforcement)
Reported Sep 12, 2012
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any…
FDA (openFDA device enforcement)
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