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Diagnostic Equipment

🏥 Medical Devices • 6,627 recalls

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

Beckman Coulter

Class I - Dangerous

The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

Mar 17, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.

Spectrum Medical

Class I - Dangerous

Medical device software marketed without FDA clearance .

Mar 19, 2025 Diagnostic Equipment View Details →

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

Siemens Healthcare Diagnostics

Class I - Dangerous

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

Mar 31, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

Spectrum Medical

Class I - Dangerous

Medical device software marketed without FDA clearance .

Mar 19, 2025 Diagnostic Equipment View Details →

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

IHB OPERATIONS B.V.

Class I - Dangerous

The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.

Mar 27, 2025 Diagnostic Equipment Nationwide View Details →

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

Abbott Molecular

Class I - Dangerous

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

Mar 20, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

Conavi Medical

Class I - Dangerous

Due to manufacturing issues there is a potential for the catheter sheath to detach.

Mar 12, 2025 Diagnostic Equipment View Details →

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.

Radiometer Medical ApS

Class I - Dangerous

ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

Mar 21, 2025 Diagnostic Equipment Nationwide View Details →

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Micro-X

Class I - Dangerous

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Apr 4, 2025 Diagnostic Equipment View Details →

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Micro-X

Class I - Dangerous

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Apr 4, 2025 Diagnostic Equipment View Details →

NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164

Medtronic Xomed

Class I - Dangerous

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

Mar 10, 2025 Diagnostic Equipment Nationwide View Details →

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

Remote Diagnostic Technologies

Class I - Dangerous

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

Apr 16, 2025 Diagnostic Equipment Nationwide View Details →

Welch Allyn Connex Vital Signs Monitor (CVSM):

Baxter Healthcare

Class I - Dangerous

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

Mar 24, 2025 Diagnostic Equipment Nationwide View Details →

Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/Part # 67NCTP-B-ECG3A; 7) ) Product Code/Part # 67NCTX-B; 8) ) Product Code/Part # 67NXEX-B; 9) ) Product Code/Part # 67NXTP-B; 10) ) Product Code/Part # 67NXTP-B-ECG3A; 11) ) Product Code/Part # 67NXTX-B; 12) ) Product Code/Part # 67NXXX-B; 13) ) Product Code/Part # 68MCTP-B; 14) ) Product Code/Part # 68MCTP-B-ECG3A; 15) ) Product Code/Part # 68MCTX-B; 16) ) Product Code/Part # 68MCXX-B; 17) ) Product Code/Part # 68MXDX-B; 18) ) Product Code/Part # 68MXEP-B; 19) ) Product Code/Part # 68MXEX-B; 20) ) Product Code/Part # 68MXTP-B; 21) ) Product Code/Part # 68MXTP-B-ECG3A; 22) ) Product Code/Part # 68MXTX-B; 23) ) Product Code/Part # 68MXTX-BR; 24) ) Product Code/Part # 68NCEP-B; 25) ) Product Code/Part # 68NCTP-B; 26) ) Product Code/Part # 68NCTP-B-ECG3A; 27) ) Product Code/Part # 68NCTX-B; 28) ) Product Code/Part # 68NCXP-B; 29) ) Product Code/Part # 68NXEP-B; 30) ) Product Code/Part # 68NXEX-B; 31) ) Product Code/Part # 68NXTP-B; 32) ) Product Code/Part # 68NXTP-B-ECG3A; 33) ) Product Code/Part # 68NXTX-B; 34) ) Product Code/Part # 68NXTX-BR; 35) ) Product Code/Part # 68NXXX-B; 36) ) Product Code/Part # 67MCTP-B; 37) ) Product Code/Part # 67MCTP-B-ECG3A; 38) ) Product Code/Part # 67MCTX-B; 39) ) Product Code/Part # 67MXEX-B; 40) ) Product Code/Part # 67MXTP-B; 41) ) Product Code/Part # 68MXXX-B.

Baxter Healthcare

Class I - Dangerous

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Mar 21, 2025 Diagnostic Equipment View Details →
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