Z-1059-2014Class II

Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error...

Name: Z-1059-2014 Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error...
Creator: Elekta, Inc.
Published: 2013-11-25
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-11-25 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of 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... on 2013-11-25. FDA classified it as Class II and gives the reason as "XVI can incorrectly calculate the target position of the treatment table". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1059-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2014-02-20
Terminated: 2017-11-24
Recalling firm: Elekta Limited
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: XVI can incorrectly calculate the target position of the treatment table.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Field Safety Notice dated November 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Potential collision risk when using XVI and external beam shaping devices released November 25, 2013 (Only software versions R4.5, R4.5.1, R4.6 and R5.0 are applicable to this recall). (All software versions R4.6 in this notices are applicable to this recall). Recommendations to Users - Monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button the FKP. To correct the error - (1) Restart XVI. (2) Put the patient in their initial setup position. (3) Scan the patient again, and continue the usual workflow. Always monitor the patient when you do RATM. When you do Volume View acquisitions with the Apex collimator attached, make sure that the stop angle of the Volume View parameters is in the lower half of the gantry rotation. This decreases the risk of a collision with the patient. Read and follow the advice int he Important Field Safety Notices and acknowledge receipt to your Elekta representative within 30 days. Corrective Action #2 - Permanent Solution - XVI Risk control measure - changes to the software to prevent table movement if the start position has not been recorded correctly. Recommendations for changes to product are - (1) Table zero should default to NIHII not zero. (2) Check that the table zero is valid because calculating absolute table positions. (3) Check prescribed table position is not more than 2.5cm from actual table position when permitting ASU from outside room. Users of software version 4.5, 4.5.1 and 4.6 will receive a mandatory upgrade to XVI 5.0. The estimated release date for the fix for the XVI 5.0 is December 2014. For further questions call ( 770 ) 300-9725.
Quantity in commerce: 1028
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CT, FL, GA, ID, IL, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, WY and DC., and the countries of Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela
Product codes and lots: Model 4.5, 4.5.1, 4.6, 5.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1059-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1059-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

Product code IYE

K100115Class IIXvi R4.5Elekta , Ltd. / cleared 2010-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)