Recalls / —

—#104873

Product

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

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K100115

Affected lot / code info

105984, 151076, 151080, 151141, 151155, 151156, 151157, 151168, 151260, 151362, 151396, 151412, 151442, 151545, 151566, 151616, 151628, 151683, 151684, 151710, 151764, 151785, 151802, 151812, 151839, 151885, 151892, 151931, 151942, 151952, 151954, 151955, 152019, 152117, 152158, 152163, 152177, 152207, 152210, 152211, 152222, 152223, 152248, 152257, 152262, 152271, 152301, 152303, 152305, 152307, 152308, 152331, 152352, 152353, 152356, 152358, 152359, 152362, 152365, 152370, 152371, 152373, 152388, 152392, 152425, 152432, 152433, 152448, 152452, 152454, 152468, 152469, 152481, 152491, 152504, 152522, 152536

Why it was recalled

The software did not operate as expected.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

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

Timeline

Recall initiated

2011-10-14

Posted by FDA

2011-12-01

Terminated

2014-11-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #104873. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.