Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not

FDA device recall Z-1059-2014 · posted 2014-02-20 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

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

Date initiated

2013-11-25

Date posted

2014-02-20

Date terminated

2017-11-24

Location

Atlanta, GA

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