FDA Device recall Z-2002-2012
Focal SIM Planning of radiation therapy
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Focal SIM Planning of radiation therapy by Elekta, citing incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2002-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-21 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
Focal SIM Planning of radiation therapy
Reason
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Identifiers
| code_info | Version 4.64.00 - 4.700, inclusive |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2002-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.