Device recall
Z-1322-2014: Integrity 1.1. Integrity is the interface and control software for the Elekta…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-1322-2014 |
|---|---|
| Recall event | 67574 |
| Product | Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2017 |
| 510(k) numbers | K112613 |
| FEI number | 1037831 |
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