Elekta, Inc. - Elekta Unity MRLinac, ImageGuided Radiation Therapy System - Class 2 Recall
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 9, 2020 Category: Medical Devices Source Type: alerts
Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2020 Category: Medical Devices Source Type: alerts
Elekta Inc - Monaco - Class 2 Recall
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan - Class 2 Recall
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan software system for radiation therapy - Class 2 Recall
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan software system for radiation therapy - Class 2 Recall
RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan software system for radiation therapy - Class 2 Recall
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan software system for radiation therapy - Class 2 Recall
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan software system for radiation therapy - Class 2 Recall
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan software system for radiation therapy - Class 2 Recall
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan software system for radiation therapy - Class 2 Recall
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan - Class 2 Recall
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff ...
Source: Medical Device Recalls - December 24, 2019 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - ORAtrac System - Class 2 Recall
MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - ORAtrac System - Class 2 Recall
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - OARtrac System - Class 2 Recall
MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
