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Browse Device Recalls

101 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 101 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 101 FDA device recalls.

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DateProductReasonClassFirm
Dec 18, 2015 Oncentra External Beam - VMAT - Radiation therapy planning system Product ... When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare... Class II Elekta, Inc.
Dec 9, 2015 MOSAIQ Oncology Information System MOSAIQ is an oncology information syste... Incorrect drug dosage due to "Age Limit" and patient weight data item issue. Class II Elekta, Inc.
Nov 24, 2015 MOSAIQ Oncology Information System. Used to manage workflows for treatment... First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies dr... Class II Elekta, Inc.
Oct 16, 2015 Monaco - Radiation Treatment Planning used to make treatment plans for patie... Unintended update of Dose and MU and Incorrect Assignment of Bolus. Class II Elekta, Inc.
Sep 15, 2015 Monaco Radiation Treatment Planning System. Used to make treatment plans f... Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple presc... Class II Elekta, Inc.
Aug 31, 2015 XiO Radiation Treatment Planning System. Used to create treatment plans for ... Incorrect Treatment Delivery Using Third Party Fixed Wedges. Class II Elekta, Inc.
Jul 1, 2015 MOSAIQ Oncology Information System MOSAIQ is an oncology information system ... A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment mach... Class II Elekta, Inc.
Jun 1, 2015 Laksell GammaPlan, a computer based dose planning system specifically designe... Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2. Class II Elekta, Inc.
May 21, 2015 Oncentra Brachy radiation therapy planning software designed to analyze and p... Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. Class II Elekta, Inc.
Jan 29, 2015 Elekta Precise Treatment Table It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are d... Class II Elekta, Inc.
Jan 7, 2015 Precise Digital Accelerator Intended to be used for radiation therapy trea... Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack ma... Class II Elekta, Inc.
Dec 19, 2014 Monaco radiation therapy treatment planning system. The Monaco system i... Incorrect CT to ED when using the Monaco Image Statistics Tool. Class II Elekta, Inc.
Dec 19, 2014 Focal Sim radiation therapy treatment planning system Incorrect CT to ED when using the Monaco Image Statistics Tool. Class II Elekta, Inc.
Nov 3, 2014 MOSAIQ Product Usage: MOSAIQ is an oncology information system used to ma... A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose ro... Class II Elekta, Inc.
Oct 6, 2014 Laksell Gamma Knife Perfexion Elekta has become aware that the latches may be locked before they have been fully turned resulti... Class II Elekta, Inc.
Aug 18, 2014 Monaco The Monaco system is used to make treatment plans for patients wit... Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic ... Class II Elekta, Inc.
Aug 18, 2014 FOCAL Sim Workstation, Radiation Treatment Planning System. Used for pat... When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Com... Class II Elekta, Inc.
May 29, 2014 MOSAIQ MOSAIQ is an oncology information system used to manage workflows f... MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other t... Class II Elekta, Inc.
May 29, 2014 iGUIDE System Product Usage: The intended use of the device is the contro... A bug in the software prevents the iGUIDE software from logging off. Class II Elekta, Inc.
May 23, 2014 MOSAIQ, an oncology information system used to manage workflows for treatment... When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and th... Class II Elekta, Inc.
Apr 23, 2014 Synergy XVI Intended for radiation therapy treatment. XVI can incorrectly calculate the target position of the treatment table. Class II Elekta, Inc.
Apr 17, 2014 HexaPOD evo RT Couchtop. To support and aid in positioning a patient durin... If screws are not properly tightened with a torque wrench they may become loose over time. Class II Elekta, Inc.
Feb 17, 2014 XiO RPT System The XiO RTP System is used to create treatment plans for an... Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used wit... Class II Elekta, Inc.
Nov 25, 2013 Synergy XVI XVI can incorrectly calculate the target position of the treat... XVI can incorrectly calculate the target position of the treatment table. Class II Elekta, Inc.
Nov 25, 2013 Agility. Version 3.1 of the Integrity interface and control software for the... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 25, 2013 Synergy XVI The Elekta Synergy S is intended to be used for radiation ther... Potential collision risk when using XVI and external beam shaping devices. Class II Elekta, Inc.
Nov 25, 2013 RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user in... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 25, 2013 XiO RTP System. Used to create treatment plans for any cancer patient for ... When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Sourc... Class II Elekta, Inc.
Nov 25, 2013 Integrity. Version 1.1 of the Integrity interface and control software for t... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 25, 2013 Desktop Pro TM linear accelerator control software intended to assist a licen... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Nov 25, 2013 XiO RTP System The XiO RTP System is used to create treatment plans for an... When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded... Class II Elekta, Inc.
Nov 25, 2013 Agility. Version 3.0 of the Integrity interface and control software for the... During the treatment table, gantry, and collimator calibration procedures, it is possible to type... Class II Elekta, Inc.
Aug 15, 2013 DMLC IV-ERGO - Beam shaping block for Radiation Therapy. Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are i... Class II Elekta, Inc.
Jul 23, 2013 Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories ... Potential for clinical errors. Class II Elekta, Inc.
Jul 2, 2013 Monaco RTP System Radiation treatment planning Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch ... Class II Elekta, Inc.
May 28, 2013 SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation th... Customers are resetting the default values outside recommended factory settings. Class II Elekta, Inc.
May 28, 2013 All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2... Customers are resetting the default values outside recommended factory settings. Class II Elekta, Inc.
May 22, 2013 Monaco RTP System Radiation Therapy Treatment Planning System. Radiation ... Patient needs to be positioned as indicated by the treatment plan. Class II Elekta, Inc.
May 1, 2013 DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear ... It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems Class II Elekta, Inc.
Apr 30, 2013 Integrity 3.0 Product Usage: The Agility multileaf collimator is indicate... Unexpected movement during beam delivery may not be detected if there are incorrect static tolera... Class II Elekta, Inc.
Mar 28, 2013 Integrity 1.1. Integrity is the interface and control software for the Ele... The problem is that the "static tolerances" from the calibration files (loaded database) are used... Class II Elekta, Inc.
Mar 14, 2013 Precise Treatment Table. To be used as part of radiation therapy treatment... The Column rotation can accidentally be moved to a different position which in the locked position. Class II Elekta, Inc.
Feb 11, 2013 Monaco RTP System. Radiation treatment planning. The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" a... Class II Elekta, Inc.
Jan 18, 2013 Elekta, Apex add-on Micro MLC, collimator for radiation therapy. If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activ... Class II Elekta, Inc.
Dec 19, 2012 Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4... The DICOM tags do not contain sufficient information for XVI to identify the different volumes th... Class II Elekta, Inc.
Sep 18, 2012 MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) u... A patient was seriously mistreated after a user made and saved an inadvertent change to the defin... Class II Elekta, Inc.
Aug 21, 2012 Oncentra External Beam 4.1. Radiation treatment planning software designed... During the planning process the beam weights can be changed by the customers. When the beam weigh... Class II Elekta, Inc.
Aug 6, 2012 Precise Digital Accelerator Delivery of radiation to defined target volumes There have been a small number of instances in hospitals where the joint between the drive gear a... Class II Elekta, Inc.
Jul 27, 2012 Multileaf Collimator To be used for single or multiple fractions, delivere... Information released with the product Agility did not originally contain information on compatibi... Class II Elekta, Inc.
Jun 21, 2012 Monaco Product Usage: Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... Class II Elekta, Inc.

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.