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Terminated

Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation therapy treatment process.

FDA Recall Z-0320-2012 · Posted 2011-12-01

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-10-14
Date Terminated2014-11-03
Product Quantity77

Reason for Recall

The software did not operate as expected.

Firm Action

Elekta sent an IMPORTANT NOTICE letter dated October 14, 2011 to all affected consignees. The letter identified the affected product, the problem, and the actions to be taken. This notice contained precautionary measures that are required for the operation of the equipment. The notice advise all customers to follow any instructions or recommendations covered in the Notice. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. For questions contact your local Elekta representative.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution (USA) - including the states of: AZ, CA, CT, GA, ID, IL, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100115XVI R4.5Elekta , Ltd. · 2010-03-10

Official Source

View FDA Recall →

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

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