Drug recall
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka…
FDA recall event 63186 · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Event ID | 63186 |
|---|---|
| Recall numbers | Z-2444-2012 |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Oct 10, 2011 |
| Report date | Oct 3, 2012 |
| Termination date | Jan 25, 2013 |
| City | Stockholm |
| Country | Sweden |
| FEI number | 3007774465 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: