MONOFLUO Pneumocystis jirovecii kit/ Bio-Rad Laboratories, Inc./ distribution error involving non-CE marked batches of MONOFLUO Pneumocystis jirovecii kits shipped to the EU, despite compliance with IVDD standards.
Trilogy EV300 Ventilator/ Philips Respironics/ aerosol deposits from in-line nebulizers in Trilogy Evo devices potentially impairing flow sensors
Laparoscopic Power Morcellators (LPM)/ All/risk of Laparoscopic Power Morcellators (LPM) dispersing cancerous cells during hysterectomy or myomectomy
MINICAP EXTEND LIFE PD TRANSFER SET/ Baxter Healthcare/ potential separation of the female connector from the main body in MiniCap Extended Life PD transfer sets
HeartStart Intrepid Monitor/Defibrillator/ Philips Healthcare/ intermittent ECG waveform display in HeartStart Intrepid Monitor/Defibrillators when using 5-Lead or 10-Lead ECG cables with the fourth limb lead placed on the patient.
lntelliVue Patient Monitor/ Philips/ potential loss of electrical grounding in IntelliVue Patient Monitors MX400–MX550
N Latex RF Kit/ Siemens Healthcare Diagnostics Inc./ Presence of white precipitates in specific vials of the N RF Reagent, potentially leading to flagged calibration, quality control errors
Atellica IM Rubella IgG/ Siemens Healthcare Diagnostics Inc./ potential for invalid calibrations with the Atellica IM and ADVIA Centaur Systems Rubella IgG assay
Q-Stress Software Version V6.1.0 -V6.4.1/ Welch Allyn Inc./ potential for duplicate Unique Identifiers (UIDs) in Q-Stress, which may lead to mismatched medical records and inaccurate ECG data
Giraffe OmniBed & Giraffe OmniBed Carestation/ improperly torqued screws securing heater doors in certain Giraffe OmniBed and Carestation devices, which may lead to loose doors
K-Systems™ G73 Block Warmer & K-Systems™ R65 Trolley/ CooperSurgical / Potential deviation in temperature regulation in K-Systems devices, where temperatures may exceed the set point
PTH STAT Elecsys cobas e 100 V2 & PTH Elecsys cobas e 100 V2/ Roche Diagnostics/ Incorrect calibration frequency setting in the electronic application files for Elecsys® PTH V2 and PTH STAT V2 assays on cobas® e 60x and cobas® e 411analyzers.
Lactate Gen.2 100 & 225 tests/ Roche Diagnostics/ Updated interference limits for NAcetylcysteinein Lactate Gen.2 assays on cobas® c systems
Vaporizer Sevoflurane, Quik-Fil/ Getinge/ chemical degradation of low-water-content Sevoflurane in specific vaporizers, leading to the potential formation of hydrogen fluoride,
Anti-TPO Elecsys E2G 300/ Roche Diagnostics/ falsely elevated recovery results with Elecsys® anti-TPO assays on cobas® e 801 and e 402 analytical units
D-Dimer Gen.2 Calibration & Control set/ Roche Diagnostics/ incorrect expiry date encoded in e-barcodes for certain lots of D-Dimer Gen.2 Calibrator and Control Sets
IgE G2 Elecsys E2G 100/ Roche Diagnostics/ discrepancy in calibration frequency for IgE II E2G assay on cobas® e 801 and e 402 modules, caused by incorrect application file settings
BD Alaris™ Pump & BD Alaris™ SYR/ BD / identified defects in the Female/Left IUI connectors of BD Alaris™ System devices, where bent or misaligned pins could disrupt connectivity
Atellica IM Total Thyroxine/ Siemens Healthcare Diagnostics Inc./ Reduction in the calibration interval for Atellica IM Total Thyroxine (T4) assays from 21 days to 4 days
Atellica CH Revised C‑Reactive Protein (RCRP)/ Siemens Healthcare Diagnostics Inc./ occurrence of 'No Calculation' flags in the Atellica CH RCRP assay on the Atellica CH Analyzer for C-Reactive Protein (CRP) concentrations below 0.05 mg/dL (<0.5 mg/L).
Iron Gen.2 (IRON 2)/ Roche Diagnostics/ throughput-dependent signal drifts in Iron Gen.2 (IRON2) assays on cobas® c 311, c 501/502, and COBAS INTEGRA® 400 plus analyzers, causing up to +4.7 μmol/L bias, especially in high-throughput settings.
BD PCR Cartridge/ Becton Dickinson /Signal drift in specific lots of BD PCR Cartridges, leading to false-positive results for influenza A in BD MAX™ RVP assays and an increased frequency of unresolved results in other molecular assays
Alanine Aminotransferase acc. to IFCC II (ALTP2) / Roche Diagnostics/ Implementation of a standardization correction factor of 1.075 for Alanine Aminotransferase acc. to IFCC II (ALTP2) in calibrators and controls, addressing minor systematic recovery deviations of patient samples.
epoc® Blood Analysis System/ Siemens Healthcare Diagnostics/ Connectivity issue in the epoc® NXS Host system
BD EpiCenter™ Microbiology Data Management System & BD Phoenix™ M50 Automated Microbiology System & BD BACTEC™ Blood Culture System & BD Phoenix™ M50 & BACTEC FX40 & BACTEC FX & BD MAX™ System/ Becton Dickinson / Potential cybersecurity vulnerabilities in BD diagnostic systems
Elecsys Folate III & Elecsys Vitamin B12 II / Roche Diagnostics/ limited onboard stability for Elecsys® Folate III and Vitamin B12 II assays on cobas® e 402 analyzers, leading to calibration failures and out-of-range QC recovery
Ultraview Universal DAB Detection Kit/ Roche Diagnostics/ inclusion of an incorrect PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONO dispenser in the ultraView Universal DAB Detection Kit
Vista 120/ Drager/ the device can freeze under certain conditions without triggering an alarm or automatic restart
Vitros XT 7600 integrated system/ QUIDEL ORTHO /Expired Signal Reagent (SR) packs may not trigger the Reagent Expired (RE) result code
Atellica CH Revised C‑Reactive Protein (RCRP)/ Siemens Healthcare Diagnostics Inc./ occurrence of 'No Calculation' flags in the Atellica CH RCRP assay on the Atellica® CH Analyzer for CRP concentrations below 0.05 mg/dL (<0.5 mg/L),
PHOS. Gen.2, 250Tests,cobas c, Integra/ Roche Diagnostics/ Calibration failures in PHOS2 and PHOU2 assays on COBAS INTEGRA® 400 plus analyzers, caused by modified photometers shifting raw absorption values beyond predefined R0 check limits.
BIOFIRE®FILMARRAY®Pneumonia Panel/ Biomerieux/ Risk of false positive Coronavirus results in BIOFIRE® FILMARRAY® Pneumonia (PN) and PNplus Panels
HeartWare TM Ventricular Assist Device (HVAD ™) System/ Medtronic/ Increased number of reports of HVAD™ controllers being inadvertently left in manual start mode during controller exchanges.
Access 2 Immunoassay Analyzer/ Beckman Coulter /Improper alignment of the sample motor to the sample wheel in certain Access 2 Immunoassay Analyzers
PHOS. Gen.2, 250Tests,cobas c, Integra/ Roche Diagnostics/ Modified photometers in COBAS INTEGRA® 400 plus analyzers, causing shifts in raw absorption values for PHOS2 and PHOU2 assays
Flow-i/ Getinge/ cybersecurity vulnerability in Flow Family Anesthesia systems (versions 4.7 and below) allowing potential remote code execution or Denial of Service (DoS) attacks during Ethernet-connected data transfers
Transfer Set (MiniCap Extended Life PD Transfer Set with Twist Clamp)/ Baxter/ potential exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs) and polychlorinated biphenyls (PCBs) in MiniCap Extended Life PD Transfer Sets with peroxide-cured silicone tubing
Access hsTnI Reagent Kit/ Beckman Coulter/ risk of cardiac troponin I (cTnI) carryover when high cTnI samples (>55,000 pg/mL) are tested using an Access assay other than Access hsTnI.
PROGRAMMER LATITUDE US/ Boston Scientific/ high battery impedance in a subset of ACCOLADE™, PROPONENT™, ESSENTIO™, ALTRUA™ 2, VISIONIST™, and VALITUDE™ pacemakers and CRT-Ps, which may trigger Safety Mode during telemetry or high-power operations
NIM Vital™ Nerve Monitoring System Stimulus Artifact/ Medtronic/ increased stimulus artifact in the NIM Vital™ Nerve Monitoring System which may result in false event detections during surgical procedures
Non-Automated Blood Pressure Gauges/ BAXTER/ The potential for Welch Allyn non-automated blood pressure gauges to fail leak and accuracy specifications after exposure to high-temperature storage
HLS Set Advanced 7.0 with BIOLINE Coating/ Getinge/ risk of compromised sterility in HLS Set Advanced 5.0 and 7.0 caused by internal packaging components puncturing the Tyvek cover
Atlan A300 & Atlan A350/ Drager/ potential failure of automatic mechanical ventilation in Dräger Atlan anaesthesia workstations, caused by an error in the motor electronics resulting from a temporary deviation in the assembly process.
Primus & Primus IE & Zeus IE/ Drager/ potential risk of incorrect connection of oxygen (O₂) reserve gas cylinders to Dräger anaesthesia workstations.
Centricity Universal Viewer/ GE HEALTHCARE/ Cybersecurity vulnerability in GE HealthCare’s Centricity Universal Viewer, where service login credentials may be exposed
Progressa bed surfaces/ Hill-Rom, Inc./ Potential issue with Progressa bed surfaces where air bladders may shift out of position when the bed head is elevated.
GOT multi SF6 & C2F6 & C3F8 / AL.CHI.MI.A. S.R.L/ Critical labeling issue with GOT multi ophthalmic gases (SF₆/C₃F₈) where similar packaging colors caused incorrect administration
DxI 9000 Immunoassay Analyzer/ Beckman Coulter/ Communication failure risk between the DxI 9000 and the host system, particularly when canceled QC test results accumulate and disrupt connectivity.
Braun Thermoscan® PRO 6000 Ear Thermometer/ baxter/ Distribution of Braun ThermoScan® PRO 6000 ear thermometers with outdated Instructions for Use (IFU).
Carestation 620/650/650c and 750/750c Anesthesia Systems/ GE HEALTHCARE/ failure in Volume Control Ventilation (VCV) mode in certain GE HealthCare Carestation 620/650/650c and 750/750c anesthesia systems
Achieva 3.0T TX/ Philips Medical Systems/ risk of patient burns caused by localized heating in Philips SENSE XL Torso (1.5T and 3.0T) MRI coils
ENDOPATH ECHELON™ Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row)/ Johnson & Johnson Medtech/ An increased rate of inadvertent instrument lockout events involving the ENDOPATH ECHELON™ Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row)
Getinge Aquadis 56/ Getinge/ potential malfunction of the Getinge Aquadis 56 Washer Disinfector caused by an unprogrammed frequency inverter.
Dexcom G7 iOS App version 2.7/ Dexcom/ Software bug in Dexcom G7 iOS App version 2.7, which may cause glucose readings to stop updating and alerts to fail
Achieva 3.0T TX/ Philips Medical Systems/ Potential adhesive failure in the Quadrature Body Coil (QBC) seal of Philips MR systems with 60 cm bores
Tina-quant® D-Dimer/ Roche Diagnostics/ elevated results were detected with the Li-heparin plasma samples when compared to citrate plasma samples.
CADD-Solis & CADD-Solis VIP Pump/Smiths Medical/ risk of false Upstream Occlusion (USO) alarms in CADD-Solis™ and CADD-Solis VIP™ infusion pumps
Urisys 1100/ Roche Diagnostics/ software encoding defect in Urisys 1100 version 7.11, causing disruption in host transmission of specific parameters (LEU, UBG, BIL, ERY)
Evis Exera III Duodenovideoscope/ Olympus/ Updated post-market surveillance data indicating an increased risk of microbial contamination when manual cleaning of TJF duodenoscopes is delayed beyond one hour
Maglife RT-1/ Schiller Medical/ eported wireless communication losses in MAGLIFE RT-1 monitors used in MRI environments
Cardiosave Hybrid and Cardiosave rescue IABP/ Getinge/ increase in reported “System Over Temperature” alarms in Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP)
Bilirubin Total Gen.3,Calibrator f.a.s,Precinorm U Plus,Precipath U Plus,Precicontrol Clinchem Multi 2,Precibil (4x2 mL)/ Roche Diagnostics/ introduction of a new reagent formulation for Bilirubin Total Gen. 3 (BILT3) in compliance with the REACH regulation
CADD SOLIS And CADD-SOLIS VIP/Smiths Medical - ICU MEDICAL/reported damage to the battery separators in the pump battery compartment of the CADD®-Solis and CADD®-Solis VIP infusion pumps
Achieva 3.0T TX/ Philips Medical Systems/ risk of adhesive failure in the Quadrature Body Coil (QBC) seal of specific Philips MR systems.
SPRINTER CART (XL)/ GETINGE/ missing safety labels on SPRINTER CART and SPRINTER CART XL infusion poles
Microstream Advance Intubated CO2 Filter Line/ Philips/ reported incidents of difficulty or inability to disconnect the CO₂ filter line airway adapter from endotracheal tubes
INNOVANCE VWF Ac/ Siemens Healthineers/ identification of potentially falsely elevated patient and quality control results when using the INNOVANCE® VWF Ac assay across various systems.
Ammonia II (300 tests)/ Roche Diagnostics/ incorrect application settings in the Ammonia II (NH3L2) assay on the cobas® c 503 analyzer
Unsaturated Iron Binding Capacity (UIBC) Reagent/ Beckman Coulter Ireland Inc./ confirmed hemolytic interference with the Unsaturated Iron Binding Capacity (UIBC) reagent
VITROS Chemistry Products Ca Slides/ QuidelOrtho/ Increased incidence of calibration failures in VITROS® Chemistry Products Ca Slides
Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration/ Covidien LLC./ difficulties in disconnecting the airway adapter from the endotracheal tube
Hugo Robotic-Assisted Surgery (RAS}/ Covidien – Medtronic/ Reported failures in the main power supply of specific Hugo™ Robotic-Assisted Surgery (RAS) surgeon consoles
Hugo Robotic-Assisted Surgery (RAS)/Covidien – Medtronic/ eported excessive torque errors in the Hugo™ Robotic-Assisted Surgery (RAS) system, which may lead to disabled instruments.
InteliQ Assayed Multiqual Control/ Bio-Rad Laboratories Inc./ Reports of lower calcium recovery in certain lots of InteliQ Assayed Multiqual Control when initially thawed
Liquichek Assayed Multiqual/Bio-Rad Laboratories Inc./ potential for initially low calcium recovery in certain lots of Liquid Assayed Multiqual (Catalog #46010 & 46020) upon thawing
Silicone hydro-coated double loop ureteral stent open-open kits/ Coloplast A/S/ translation error in the Arabic version of the Instructions for Use (IFU)
PrisMax and TherMax/ Baxter Healthcare SA/ Reported issues including false alarms related to air detection, blood leak, and disposable detection failures
Vista 120/ Drager/ Potential issue where Vista 120 monitors may freeze under certain conditions without triggering an alarm or automatic restart
Atellica CH Urinary/Cerebrospinal Fluid Protein/Siemens Healthcare Diagnostics Inc./ Potential for falsely depressed results with the Atellica CH UCFP assay
Atellica CH Revised C-Reactive Protein (RCRP)/ Siemens Healthcare Diagnostics Inc./ Incorrect software flagging in the Atellica CH Revised C-Reactive Protein (RCRP) assay.
FLEX Monoclonal Mouse Anti-Human Ready-to-use antibody CD20cy Clone L26 on Dako Omnis/ Agilent Technologies, Inc./ weak immunohistochemistry staining observed in some CLL/SLL tissue samples using GA604 (CD20cy antibody Clone L26)
Dexcom G6 iOS App/ Dexcom/ software issue in the App (versions 1.11.2 and 1.12.0), where users may temporarily see outdated glucose readings upon reopening the app
CEILING TUBE SUPPORT CH-200 /Shimadzu Corporation/ potential risk of shaft breakage in the ceiling tube support CH-200
Becker and Exacta external drainage and monitoring systems (EDMS)/ Medtronic Inc./ The potential for cracking and leaking in the “stopcock” component on Becker and Exacta EDMS.
Hyperbaric Oxygen Therapy (HBOT) Devices FSN
Heater Unit HU 35, 230V FSN
Salem Sump PVC Gastroduodenal Tube FSN
Evis Exera III Duodenovideoscope FSN
EASY PULSE FSN
FreeGo Screwcap Set with ENPIus adapter and ENFit stopcock port and connector & FreeGo 1.5 Litre Feed Bag set with ENFit stopcock port and connector FSN
DxI 9000 Access Immunoassay Analyzer FSN
CombiDiagnost R90 FSN
ELECTROLYTE ANALYZER W/O STARTERKIT 9180 FSN
ULTRAMAT S FSN
Kendall SCD™ 700 Sequential Compression System FSN
Atellica CH Triglycerides_2 (Trig_2) FSN
Automated Digital Cell Morphology Analyzer DI-60
SINGLE USE LIGATING DEVICE POLYLOOP FSN
Welch Allyn non-automated blood pressure gauges FSN
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