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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 10 Results
510(K) Number: K210500
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Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1... 2 10/14/2021 FEI # 3015232217
ELEKTA SOLUTIONS AB
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta ... 2 01/23/2026 FEI # 1037831
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy Sy... 2 12/01/2023 FEI # 1037831
Elekta, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerat... 2 12/01/2023 FEI # 1037831
Elekta, Inc.
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiati... 2 12/01/2023 FEI # 1037831
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation T... 2 12/01/2023 FEI # 1037831
Elekta, Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accel... 2 12/01/2023 FEI # 1037831
Elekta, Inc.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle... 2 12/01/2023 FEI # 1037831
Elekta, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; ... 2 05/30/2023 FEI # 1037831
Elekta, Inc.
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accele... 2 10/14/2021 FEI # 1037831
Elekta, Inc.
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