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Terminated

Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

FDA Recall Z-0305-2012 · Posted 2011-11-29

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-03-09
Date Terminated2012-08-09
Product Quantity56

Reason for Recall

If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value.

Firm Action

Elekta sent an IMPORTANT NOTICE letter dated March 9, 2011 to affected customers. The notice identified the product, the problem, and the corrective action to be taken by the customer. The notice advise all customers to follow any instructions or recommendations covered in the Notice. For questions call +44(0)1293 654200.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution (USA) including the states of: AZ, CA, GA, IL, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, TN, VA, WI and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051932ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5Elekta, Inc. · 2005-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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