Recall Z-1059-2014— Elekta, Inc.

Name: FDA recall Z-1059-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-25

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-11-25, terminated 2017-11-24. It names one FDA 510(k) clearance: K100115. 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..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Terminated: 2017-11-24
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K100115 — XVI R4.5Elekta , Ltd.·cleared 2010-03-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

XVI can incorrectly calculate the target position of the treatment table.

Data sourced from openFDA. This site is unofficial and independent of the FDA.