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Browse Device Recalls

113 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 113 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 113 FDA device recalls.

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DateProductReasonClassFirm
Jun 8, 2021 RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1... Initial delivery positions will be set incorrectly when having setup beam(s) at the localization ... Class II RAYSEARCH LABORATORIES AB
Apr 21, 2021 RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 ... Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after ... Class II RAYSEARCH LABORATORIES AB
Apr 7, 2021 RayStation standalone software radiation therapy treatment planning system. ... When using more than one plan in a treatment course, the Total dose display in Dose tracking ma... Class II RAYSEARCH LABORATORIES AB
Mar 25, 2021 RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.... Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. Class II RAYSEARCH LABORATORIES AB
Mar 3, 2021 RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information s... Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCa... Class II RAYSEARCH LABORATORIES AB
Feb 22, 2021 RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7,... For some LINAC types, merging clinical beams with beams of approximate dose may lead to the appro... Class II RAYSEARCH LABORATORIES AB
Nov 11, 2020 RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B... Two issues were found with the treatment plan report: 1) There may be incorrect information for t... Class II RAYSEARCH LABORATORIES AB
Oct 8, 2020 RayStation standalone software treatment planning system, Model No. 4.0, 4.5,... If a region of interest (ROI) or point of interest (POI) that is referenced from an imported pla... Class II RAYSEARCH LABORATORIES AB
Jul 29, 2020 RayCare, device is stand-alone software - Product Usage: used to support work... When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image re... Class II RAYSEARCH LABORATORIES AB
May 26, 2020 RayStation standalone software treatment planning system (RayStation 8A, 8B, ... It is not obvious that the manual import of a treatment record into RayCare PACS does not automat... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radi... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Produ... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy a... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation ... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radi... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy an... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy an... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radi... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy a... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy a... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiat... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiat... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radi... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
May 18, 2020 RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radia... Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calcu... Class II RAYSEARCH LABORATORIES AB
Mar 4, 2020 RayStation standalone software treatment planning system, Model Numbers 4.0, ... Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtu... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment ... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment ... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone softw... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone soft... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Feb 20, 2020 RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone softw... There is a potential for erroneous propagation of the current tabletop positions when applying pi... Class II RAYSEARCH LABORATORIES AB
Dec 19, 2019 RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4... Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module ma... Class II RAYSEARCH LABORATORIES AB
Nov 18, 2019 RayStation stand-alone software treatment planning system, Model Numbers 4.0,... Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of... Class II RAYSEARCH LABORATORIES AB
Nov 12, 2018 RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,... Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, Ray... Class II RAYSEARCH LABORATORIES AB
Sep 21, 2018 RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, ... Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5... Class II RAYSEARCH LABORATORIES AB
Jun 29, 2018 RayStation stand-alone software treatment planning system, RayStation 4.5, R... If the beam model has a highly asymmetric primary source, it is not correctly taken into account ... Class II RAYSEARCH LABORATORIES AB
Jun 6, 2018 RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, ... The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous... Class II RAYSEARCH LABORATORIES AB
Mar 28, 2018 RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 ... The dose calculation accuracy may in some situations be less than expected. The user must be awar... Class II RAYSEARCH LABORATORIES AB
Jan 26, 2018 Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build... Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment v... Class II RAYSEARCH LABORATORIES AB
Nov 20, 2017 RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,... When calculating electron Monte Carlo dose with a very large number of histories, the dose calcul... Class II RAYSEARCH LABORATORIES AB
Jul 17, 2017 RayStation Product Usage: is a software system designed for treatment pl... For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout positi... Class II RAYSEARCH LABORATORIES AB
Jan 18, 2017 Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation ... An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software pro... Class II RAYSEARCH LABORATORIES AB
Nov 9, 2016 RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System... Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation ... Class II RAYSEARCH LABORATORIES AB
Oct 11, 2016 Radiation Therapy Treatment Planning System Product Usage: RayStation is... An error may occur with the display of dose computed on images other than the planning CT (auxili... Class II RAYSEARCH LABORATORIES AB
Sep 1, 2016 RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radi... RaySearch became aware of the problem as it was discovered in cooperation with a customer experim... Class II RAYSEARCH LABORATORIES AB
Jul 1, 2016 RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.... An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation... Class II RAYSEARCH LABORATORIES AB
May 30, 2016 Radiation Therapy Treatment Planning System, Model 5.0 For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in ... Class II RAYSEARCH LABORATORIES AB
Feb 10, 2016 RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4... A software issue with editing tools that use the left mouse button held down, for drawing in and ... Class II RAYSEARCH LABORATORIES AB

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.