Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process.

FDA device recall Z-0342-2012 · posted 2011-12-01 · Terminated

Recall details

Recalling firm

Elekta, Inc.

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.

Action taken

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

Status

Terminated

Product code

IYE

Quantity affected

123

Distribution

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, &

Date initiated

2011-10-20

Date posted

2011-12-01

Date terminated

2012-08-09

Location

Norcross, GA

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