Elekta Recalls
61 recalls on record in the United States
Elekta Limited recalls Integrity R1.2
Potential for positional errors following automatic table movement (ATM).
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Elekta Limited recalls Agility with Integrity R3.2
Potential for positional errors following automatic table movement (ATM).
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Elekta Inc recalls Elekta ERGO++ Product Usage: ERGO is often used for ster
Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
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Elekta, Inc. recalls MOSAIQ Medical Charged-Particle Radiation Therapy System
The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
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Elekta, Inc. recalls iGUIDE Software 2.2 Product Usage: Control of accurate
Incorrect PEC values.
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Elekta, Inc. recalls Leksell Gamma Knife Icon is a teletherapy device intended fo
If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.
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Elekta, Inc. recalls MOSAIQ(R) Oncology Information System, Versions 2.50.05 and
Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.
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Elekta, Inc. recalls Monaco RTP System. Used to make treatment plans for patie
Incorrect dose after editing beam number an wedge angle.
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Elekta, Inc. recalls Monaco RTP System Product Usage: Used to make treatment
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
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Elekta, Inc. recalls Oncentra External Beam Oncentra Brachy Product Usage: On
Cross profile for Varian 60 degree wedge shows "horns."
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Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
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Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
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Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name:
Due to a manufacturing issue and electrical grounding of systems.
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Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy Lic
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
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ELEKTA SOLUTIONS AB recalls MOSAIQ Oncology Information System Software Builds 3.1.3,
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
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Elekta, Inc. recalls Brand Name: Leksell Stereotactic System Product Name: Lekse
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
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Elekta, Inc. recalls MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
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Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic
Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.
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Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
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Elekta, Inc. recalls ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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Elekta, Inc. recalls ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 85
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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Elekta, Inc. recalls ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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Elekta, Inc. recalls ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Par
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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Elekta, Inc. recalls ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medic
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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Elekta, Inc. recalls ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MR
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containin
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
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Elekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the bel
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
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Elekta Instrument AB recalls Instructions for Use for the following Leksell Stereotactic
The incorrect IFU was distributed with the devices.
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Elekta Inc recalls Monaco RTP System. Used to make treatment plans for pat
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
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Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
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Showing 30 of 61 recalls. See all →