Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2444-2012 — SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, gen

U.S. FDA — Device Enforcement · Sweden · 2011-10-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2444-2012
Date of alert: 2011-10-10
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: RAYSEARCH LABORATORIES AB
Product category: device
Product type: Devices

Reported risk: This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not 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 delivered treatment. The behavior appears, when importing RFA-files (.asc)

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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