Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a li

FDA device recall Z-1411-2010 · posted 2010-04-22 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction.

Action taken

The following Important Notices were sent to customers: 1) Important Notice A305-Possible Synergy XVI panel position error (dated September 19, 2007) was sent to customers with versions R3.5, R4.0 and R4.1., 2) Important Notice A306-Possible Synergy XVI panel positioning error (dated November 8, 2007) was released to encompass customers with version R4.2., and 3) Important Notice A328 dated March 10, 2009, and sent again on April 29, 2009, included a modification kit to address the original issue and an expanded range of serial numbers affected. This Important notice A328 entitled, Elekta Synergy kV Detector Position Readback Modification Kit supersedes A305 and A306 for customers who have serial numbers within the range specified. The letter describes the product and the problem and advises the customer to follow any instructions or recommendations covered in this Notice. If you have any questions, please contact Elekta at 770-670-2548.

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

166 units

Distribution

Worldwide distribution: USA and Puerto Rico, Canada and Mexico.

Date initiated

2007-09-19

Date posted

2010-04-22

Date terminated

2012-08-09

Location

Norcross, GA

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