Elekta Synergy XVI recallZ-1411-2010 · Elekta, Inc. · initiated Sep 19, 2007
Terminated All recalls posted in April 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1411-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 19, 2007
- Posted by the FDA
- Apr 22, 2010
- Recalling firm
- Elekta, Inc.
- Quantity
- 166 units
- Product code
- IYE
- FDA submissions
- K051932
- Distribution
- Worldwide distribution: USA and Puerto Rico, Canada and Mexico.
Product description
Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Other devices under the same FDA submission
1 device cleared under K051932 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 1525717Elekta Limited · Accelerator, linear, medical1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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