FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
- Recall number
- Z-1411-2010
- Recalling firm
- Elekta, Inc.
- Product
- Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
- Status
- Terminated
- Initiated
- 2007-09-19
- Posted
- 2010-04-22
- Terminated
- 2012-08-09
- Reason
- 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
- Device Design
- Action
- 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.
- Quantity
- 166 units
- Distribution
- Worldwide distribution: USA and Puerto Rico, Canada and Mexico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K051932"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28