Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
763 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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FIAB SpA, FSN-FSCA nr. 139, Pads for Defibrillation "Bexen Cardio"
The system for connecting the electrodes to the AED consists of a “main body” connector and an “adapter identifier” for pediatric ...
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Thermo Fisher Scientific, FSN-2022-002, ARIS HiQ
If an ESD pulse from a build-up of static electricity is discharged on the HiQ front door it can cause the instrument to go into ...
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STRYKER ENDOSCOPY, RA2022-2912780, 1688 Camera Control Unit (CCU)
A software defect has been identified in the 1688 Camera Control Unit (CCU) that will cause the image on the monitor to flip ...
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Mikrogen GmbH, FSN-DE/202001, ampliCube HEV 2.0 quant
With this letter we would like to inform you about a mistake in the instructions for use of our ampliCube HEV 2.0 Quant (Art. no. ...
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Sysmex FSN524700045 - FLUOROCELL PLT
Unfortunately it has come to our attention that Sysmex haematology IVD reagent Fluorocell PLT might show a decrease of the side ...
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Wright Medical Technology, FSN-PFA 2856919, CLAW™ II ORTHOLOC 3DSi Plate/DARCO™ Screw, Locking
Subsequent to receiving a non-conforming event report, an internal investigation was conducted and confirmed that two specific ...
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Stryker Spine, RA2021-2895946, Everest XT MI Inner Dilator and Outer Dilator
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators, catalog numbers 5101-90167 and ...
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Thermo Fisher Scientific FSN-2021-014 - Cefiderocol on Sensititre plates
Potential for False Susceptibility for some Gram-Negative species due to broth performance variation.
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Seemann Technologies 012021 - Sterile disposable bipolar forceps cable
The sterile disposable bipolar forceps cables are listed on the EC Directive certificate of the Notified Body not as a Class I ...
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NuVasive, Precice Unyte and Short IFU Update FSN, Precice System
NuVasive Specialized Orthopedics, Inc. (NSO) voluntarily issues this Field Safety Notice (FSN) to inform healthcare providers of ...