Ferno-Washington Power F2 Powered Fastening System
The Power F2 Powered Fastening System may have intermittent loss of powered function, causing reduced performance or delays in patient transport.
Medical device recalls
Medical device recalls from FDA, newest first.
1 recall
1 recall
Steris HexaVue Focus Integration System
HexaVue Focus Integration System may mismatch patient information on manually printed images, causing documentation discrepancies.
1 recall
Nihon Kohden CNS-6200 Series Central Nurse Station
The Nihon Kohden CNS-6200 Series Central Nurse Station has a cybersecurity issue that could disrupt monitoring and alarm visualization.
2 recalls
Beckman Coulter DxC 500 Clinical Chemistry Analyzers
DxC 500 AU and DxC 500i analyzers have a software issue that can revert test units to default without warning, causing falsely elevated results.
2 products
Spectral CT and Spectral CT 7500 RT
Spectral CT and Spectral CT 7500 RT have software issues that may affect safety and performance.
1 recall
Beckman Coulter Chemistry Analyzer AU480
When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started.
1 recall
Tandem T:Slim Mobile Application
The t:slim iOS app has a software issue preventing pairing with CGM sensors, which could lead to hypoglycemia or hyperglycemia.
3 recalls
Philips MRI Scanners and Upgrade Kits
Ingenia Blue Seal SE and Blue Seal XE export incorrect diffusion data when using Enhanced MR Dicom format.
12 productsUnited Imaging Computed Tomography and Positron Emission Tomography Systems
The systems have a software problem when Split or Local function is enabled and multiple RIS exams are merged into a single study.
12 productsVolcano Philips IntraSight Plus
The Philips IntraSight Plus may associate image data with another patient's record, potentially causing incorrect diagnosis or treatment.
2 recalls
Philips Achieva, Ingenia, Intera and MR MRI Systems
A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted.
12 products
Philips EPIQ Elite Diagnostic Ultrasound System
The Philips EPIQ Elite ultrasound system has a software issue that can cause inaccurate blood flow measurements and misdiagnosis.
1 recall
VERIQA RT MonteCarlo 3D v3 Software
The software accounts for a bolus in a treatment plan but does not display it clearly.
2 recalls
Philips Patient Information Center iX and Philips PIC iX Essentials
Philips Patient Information Center iX may freeze and become unresponsive due to software malfunction.
2 products
StatStrip Glucose Meters
The StatStrip Glucose Hospital Meter System may show a previously scanned barcode.
5 products
2 recalls
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System
The Insertable Cardiac Monitor System may delay AF Burden Alert notifications, potentially delaying clinical evaluation.
3 products
Medos International Velys Enabling Tech Robotic-Assist Station
The Velys Enabling Tech Robotic-Assist Station has a software issue that may cause unintended movement of the robotic arm.
1 recall
Baxter Novum IQ Syringe Pump
The syringe pump has a software issue that may occur during multi-syringe infusion.
2 products
1 recall
GE Portrait Core Services Software
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer.
4 products1 recall
FUJIFILM Synapse PACS Software
The software may cause the ruler measurement to be inaccurate.
1 recall
Merge PACS and Merge OrthoPACS, Medical Imaging Diagnostic Workstation
The medical imaging diagnostic workstation may display measurements inaccurately due to a software issue.
1 recall
Beckman Coulter DxC 500I Clinical Analyzer Modules
Beckman Coulter DxC 500i Clinical Analyzer Modules have a software defect that can cause erroneous patient test results.
2 products2 recalls
Paragonix Technologies KidneyVault Portable Renal Perfusion System
The KidneyVault Portable Renal Perfusion System may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Foundation Medicine Hamilton Microlab STAR Liquid Handler
The Hamilton Microlab STAR Liquid Handler has a software issue that can cause spontaneous software closures.
3 recalls
Philips Azurion
Philips Azurion x-ray system has software issues that may delay therapy and cause procedural complications.
Philips Azurion Interventional Fluoroscopic X-Ray Systems
Philips Azurion Rystem has software issues that may delay therapy and cause procedural complications.
Philips Allura Xper FD Interventional Fluoroscopic X-Ray Systems
Allura Xper FD has a firmware issue that could lead to loss of geometry movements.
1 recall
Beckman Coulter MicroScan LabPro Panel Update Software
MicroScan LabPro V5.03 Panel Update 11 has incorrect algorithms that may affect antimicrobial susceptibility test results.
2 products
2 recalls
GE Healthcare Portrait Core Services Software
GE Healthcare Portrait Core Services SW V 1.2.0 patient monitoring system has a software vulnerability that may allow unauthorized access.
GE Healthcare MAC VU360 Electrocardiographs
After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity.
3 recalls
Munevo DRIVE and Munevo DRIVE R-Net Powered Wheelchair Hands-Free Control Application
A software issue may cause the wheelchair's driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.
Copan WASPLab Automated Culture Plate Incubators and Imagers
WASPLab has a software issue that may prevent users from overwriting results.
Normand Info REMISOL Advance Data Manager
REMISOL Advance Data Manager software may replace final combo test results with sub-results, causing incorrect reporting.
2 recalls
MiniMed Go App
The MiniMed Go App may miss nighttime alerts, leading to missed insulin doses and increased hyperglycemia risk.
SafeOp Patient Interface
The device may experience loss or interruption of triggered electromyography functionality during use.
2 recalls
SnapshotGLO Wound Imaging Device
The SnapshotGLO Wound Imaging Device can become temporarily unusable when its battery fully discharges into shipping mode.
Boston Scientific TheraSphere 360 Y-90 Management Platform
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input.
2 recalls
Wilcox BOSS Xe Family
The BOSS Xe family has a software enhancement to increase safety and all units should be returned.
3mensio Workstation (Vascular Fenestrated) Software
The software may report a measurement larger than the actual anatomical dimension.
1 recall
Versius Surgical System
The Versius Surgical System has a cybersecurity risk because Secure Boot was not enabled.
1 recall
MiniMed 780G Insulin Pump
The MiniMed 780G Insulin Pump can stop delivering insulin due to a software anomaly, leading to delayed therapy and increased risk of hyperglycemia or DKA.
1 recall
Thuvera Laser Console
The Thuvera Laser Console has a software anomaly that causes a false display of error code 5018.
1 recall
STAAR ICL Calculation Software
The STAAR ICL Calculation Software has a coding issue that affects the implant orientation diagram printout.
1 recall
Medtronic O-Arm O2 Imaging System
The O-arm O2 Imaging System may show image artifacts due to a detector panel firmware anomaly.
2 products
1 recall
Automated Impella Controller (AIC)
The Automated Impella Controller has a potential software error when used with left ventricular Impella devices.
2 recalls
MOSAIQ Oncology Information System
MOSAIQ Oncology Information System software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.
Merlin Patient Care System (PCS)
Software malfunction may occur during pacing capture threshold test.
1 recall
Micromed S.P.A. Natus SD LTM 64 PLUS EEG Amplifier/recorder
The SD LTM 64 PLUS EEG amplifier may show a 1-second delay between channels, potentially leading to misinterpretation of results.
2 recalls
Fresenius Kabi Ivenix Infusion System LVP Software
The LVP software of the Ivenix Infusion System can report a false battery-health value and trigger a battery-depletion alarm.
GE MAC 5 Resting ECG Analysis Systems
Software in development was made available for customer use, which can associate clinical information with the incorrect patient.
