Elekta, Inc. Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
Serial Numbers: 151008, 151024, 151025, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446 and 151479.
Products Sold
Serial Numbers: 151008, 151024, 151025, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446 and 151479.
Elekta, Inc. is recalling Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norc due to It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
Recommended Action
Per FDA guidance
Elekta, Inc. issued an "Important Notice" dated December 12, 2008. Customers were informed of the affected device and instructed on proper steps until an update is provided. For further information, contact Elekta, Inc. at 1-770-300-9725.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026