Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process.
FDA Recall Z-0342-2012 · Posted 2011-12-01
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-10-20
Date Terminated2012-08-09
Product Quantity123
Reason for Recall
A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.
Firm Action
The firm, Elekta, issued a "FIELD CHANGE ORDER MANDATORY ACTION" notice dated October 20, 2011 to its customers to add fuse protection for the kV transformers. The notice describes the product, problem, provides instructions and procedures and actions to be taken. The customers were instructed to follow any instructions or recommendations covered in the notice and to file the document in the Important Notice section of the appropriate User Manual. Elekta will contact the customer if the FCO is applicable to their kV generator.
If you have any questions, call 770-300-9725.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution: USA including states of: AL, AK, AZ, CA, CT, FL, GA, IL, IA, KY, MD, MS, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TX, VT, VA, WA, WV, WI, Puerto Rico, & DC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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