Device recall
Z-2444-2012: SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10)…
FDA device recall · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Recall number (Z-number) | Z-2444-2012 |
|---|---|
| Recall event | 63186 |
| Product | 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… |
| Product code | MUJ |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2013 |
| 510(k) numbers | K083264 |
| FEI number | 3007774465 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database