—#125047

Product

Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051932
Affected lot / code info: Model 4.2.1

Why it was recalled

Potential collision risk when using XVI and external beam shaping devices.

Root cause (FDA determination)

Software design

Action the firm took

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. Corrective Action #1 - Potential collision risk when using XVI and external beam shaping devices. (Only software version R4.2.1 from this notice 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 on 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 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 in the Important Field Safety Notice (200 01 507 081) 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. Target Release XVI R.4.2.2 estimated for release April 2014. For further questions please call (770) 300-9725.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Pakistan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, and United Kingdom.

Timeline

Recall initiated: 2013-11-25
Posted by FDA: 2014-02-20
Terminated: 2016-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125047. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.