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Synergy XVI recallZ-1061-2014 · Elekta, Inc. · initiated Nov 25, 2013

Class II Terminated All recalls posted in February 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1061-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 25, 2013
Posted by the FDA
Feb 20, 2014
Recalling firm
Elekta, Inc.
Quantity
312
Product code
IYE
FDA submissions
K051932
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

Model 4.2.1

Other devices under the same FDA submission

1 device cleared under K051932 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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