Browse Device Recalls
3,235 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,235 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 3,235 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... | Class II | Volcano Corporation |
| Jun 15, 2015 | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1... | Software bug was found where there was no difference in Total and Corneal high-order aberrations,... | Class II | Nidek Inc |
| Jun 5, 2015 | Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStar... | Multiple software and hardware issues with device that can affect its function. | Class II | Philips Electronics North America Corporation |
| May 31, 2015 | The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2... | Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to f... | Class II | Merge Healthcare, Inc. |
| May 29, 2015 | Radiation Therapy Treatment Planning System software RayStation is a softw... | An error caused by a floating point precision problem tends to cause a problem with the display o... | Class II | RAYSEARCH LABORATORIES AB |
| May 29, 2015 | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A an... | When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of d... | Class II | Siemens Medical Solutions USA, Inc. |
| May 22, 2015 | Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego system... | There exists a possible position sensor fault in the swivel base axis not being detected by the s... | Class II | Siemens Medical Solutions USA, Inc |
| May 21, 2015 | Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimensi... | Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop process... | Class II | Siemens Healthcare Diagnostics, 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. |
| May 19, 2015 | CentraLink" Data Management System; software is a network solution provider a... | Siemens Healthcare Diagnostics has determined that the sample query function that includes Instr... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2015 | Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catal... | Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or hi... | Class II | Philips Ultrasound, Inc. |
| May 15, 2015 | Syngo.via and Syngo.x ; a software solution intended to be used for viewing, ... | measurements drawn on the 2nd and subsequent images of the series are not visible on printouts wh... | Class II | Siemens Medical Solutions USA, Inc |
| May 13, 2015 | Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us... | An issue with the cancel functionality used during atypical infusion programming to cancel user i... | Class II | CareFusion 303, Inc. |
| May 8, 2015 | RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment P... | RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VM... | Class II | RAYSEARCH LABORATORIES AB |
| May 8, 2015 | Celesteion PCA-9000A/2 PET/CT System | It was found that if specific operations are performed in multi-phase helical scanning, the acqui... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation... | Instances of data sets not being accurately registered to the patient anatomy were observed. | Class II | Brainlab AG |
| May 7, 2015 | Treatment Planning and Delivery System Software version 3.6. ViewRay. Ind... | The software was failing to determine new patient locations if imaging is not enabled during trea... | Class II | Viewray Incorporated |
| May 2, 2015 | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e,... | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1... | Class II | Neusoft Medical Systems Co., Ltd. |
| Apr 29, 2015 | EasyLink Data Management System; a clinical data management system that assis... | System Limitations and Software Issues related to the following features: Custom reference range... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 23, 2015 | Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The ... | A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in th... | Class II | Philips Medical Systems, Inc. |
| Apr 20, 2015 | SOMATOM Perspective; the intended use of computed tomography is to produce cr... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2015 | SOMATOM Emotion 16, the intended use of computed tomography is to produce cro... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2015 | SOMATOM Emotion 6; the intended use of computed tomography is to produce cros... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2015 | MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) | The operator console allows users to deliver therapeutic radiation to patients even though a spec... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Apr 14, 2015 | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer applicat... | The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could... | Class II | bioMerieux, Inc. |
| Apr 14, 2015 | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24,... | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail... | Class II | Nihon Kohden America Inc |
| Apr 14, 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity CT Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 13, 2015 | SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system,... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fl... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2015 | Merge RadSuite software. Radiological image processing system. | When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it ... | Class II | Merge Healthcare, Inc. |
| Apr 8, 2015 | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Editi... | Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possib... | Class II | Baxter Corporation Englewood |
| Apr 6, 2015 | VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-... | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of t... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | Assay Data Disk (ADD), All DRV versions that support product within expiry da... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2015 | VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre... | Software anomaly regarding urine samples that require acidified pretreatment. The software has a... | Class II | Ortho-Clinical Diagnostics |
| Apr 1, 2015 | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the... | If a user requests slides from the LIS or TPID, then updates a request by changing the test, the ... | Class II | Dako North America Inc. |
| Apr 1, 2015 | Patient Handling System (Motion Control Software), Product Usage: Indica... | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS... | Class II | Viewray Incorporated |
| Mar 27, 2015 | The eCareManager system. Software intended for use in data collection, stora... | A software defect may cause incorrect medication order change. If the user decides to edit the o... | Class II | Visicu, Inc. |
| Mar 25, 2015 | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. | Device software treatment preset parameters for the XC treatment handpiece do not match the Opera... | Class II | Lumenis Limited |
| Mar 25, 2015 | Universal Charger Product Usage: The Stryker Universal Battery Charg... | The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Mar 24, 2015 | Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers fo... | Customer reports that the ventilator display can freeze. Ventilation continues but the informatio... | Class II | Hamilton Medical, Inc. |
| Mar 23, 2015 | Sedecal SA Mobile Diagnost w DR x-ray system | Due to a software defect, the system may sporadically apply the default x ray exposure parameters... | Class II | Sedecal USA, Inc. |
| Mar 12, 2015 | Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with A... | Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is ... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Mar 10, 2015 | Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Numb... | Software Anomaly; It is possible for the device to process samples with a cartridge other than th... | Class II | Ortho-Clinical Diagnostics |
| Mar 9, 2015 | GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INF... | GE Healthcare has become aware of a potential safety issue involving MRI systems due to software ... | Class II | GE Healthcare |
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.