—#89892

Product

Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051932
Affected lot / code info: 134351, 134524, 134723, 135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135068, 135071, 135072, 135073, 135076, 135078, 135079, 135081, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135104, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135133, 135142, 135144, 135150, 135151, 135157, 135158, 135163, 135164, 135167, 135168, 135170, 135172, 137173, 135175, 135177, 135181, 135182, 135184, 135189, 135191, 135190, 135192, 135195, 135196, 135199, 135200, 135206, 135207, 135208, 135209, 135210, 135211, 135215, 135216, 135225, 135226, 135227, 135230, 135233, 135235, 135237, 135241, 135247, 135251, 135256, 135258, 135259, 135262, 135265, 135267, 135271, 135272, 135273, 135274, 135277, 135278, 135284, 135285, 135287, 135288, 135291, 135292, 135296, 135298, 135300, 135303, 135305, 135306, 135313, 135316, 135323, 135324, 135326, 135328, 135331, 135332, 135334, 135335, 135336, 135337, 135340, 135341, 135343, 135346, 135347, 135348, 135351, 135352, 135353, 135355, 135356, 135359, 135361, 135367, 135368, 135382, 135383, 135384, 135389, 135391, 135393, 135394, 135412, 135413, 135420, 135446, 135455, 136125, 136126, 136127, 136176, 136244

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

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

Timeline

Recall initiated: 2007-09-19
Posted by FDA: 2010-04-22
Terminated: 2012-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.