FDA Device recall Z-1059-2014
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequent…
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequent… by Elekta, citing XVI can incorrectly calculate the target position of the treatment table.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1059-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-25 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.
Reason
XVI can incorrectly calculate the target position of the treatment table.
Identifiers
| code_info | Model 4.5, 4.5.1, 4.6, 5.0 |
|---|
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-1059-2014%22
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