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16 thg 9, 2026•1 phút đọc
ICCA Releases J.06.01 & J.06.02 Alerts: Auto-Charting May Cause Fluid-Balance Errors
ICCA's J.06.01 and J.06.02 releases warn that auto‑charting of infusion data can produce incorrect intake, output and net body balance values for units using automatic charting settings.
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10 thg 9, 2026•1 phút đọc
Beckman Coulter DxC 500i and DxC 500 AU Analyzers Software Issue May Reset Units on Plasma Tests
Beckman Coulter reports a software flaw in DxC 500i and DxC 500 AU clinical chemistry analyzers that can revert user-selected units to defaults when plasma samples are tested, without warning.
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9 thg 9, 2026•1 phút đọc
Philips MR Imaging Systems Software Issue May Halt Exams
Philips reports a software fault in MR systems (versions R5 & R11) that can freeze the system during image reconstruction, requiring a restart.
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4 thg 9, 2026•1 phút đọc
Gore Reports Quality Issue with VIABAHN® Devices Potentially Affecting Tip Bonding
Gore discovered some VIABAHN® devices were processed on equipment outside the validated range, potentially causing incorrect distal tip bonding.
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2 thg 9, 2026•1 phút đọc
Stryker LP35 Defibrillator Fails to Show “Check Rhythm” Prompt
Health Canada reports Stryker’s LP35 may not display the “CHECK RHYTHM / ECG Analysis Inconclusive” message, though shock advisories and therapy remain unaffected.
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28 thg 8, 2026•1 phút đọc
Cynosure DermaV Laser System Reports Spark Noise and Burn Risks in Vascular Treatments
Cynosure Lutronic reports patient burn incidents linked to spark and loud noise during DermaV laser vascular procedures.
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27 thg 8, 2026•1 phút đọc
Health Canada Issues Alert on Maquet Percutaneous Insertion Kit Sterile Packaging
Health Canada reports failures in sterile barrier integrity testing for Maquet percutaneous insertion kits, limiting the FSCA to all PIK line products within shelf‑life.
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26 thg 8, 2026•1 phút đọc
Draeger Alerts Potential Hose Cracks in VentStar Resus Neo and Resuscitaire Devices
Draeger reports users have found visible hose cracks in VentStar® Resus Neo and Resuscitaire devices before use; no health impacts reported but risk cannot be excluded.
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24 thg 8, 2026•1 phút đọc
Health Canada issues alert for Aisys™ Carestation™ and CS² anesthesia systems
Health Canada warns that certain Aisys™ Carestation™ and Aisys™ CS² anesthesia systems with specific electronic gas mixer assemblies may automatically switch to Alternate O₂ control.
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