Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.325 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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St. Jude Medical, FA-Q123-HF-2 Sensor Operating, CardioMEMS PA Sensor and Delivery System
The CardioMEMS HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number ...
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B.Braun Melsungen, FSN-2023-01-20, INF.SP.LINE,TRANS,PVC,LL,250CM-EU
Tijdens onze post-market surveillance-activiteiten zijn kwaliteitsproblemen vastgesteld die specifiek betrekking hebben op de ...
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GE Healthcare, FMI 36154, Frame F2-01
CARESCAPE ONE (CS ONE) patiëntmonitor potentiële laadonderbreking bij gedeeltelijk ontkoppelen met F2-01 frame.
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Stryker -Mobius Imaging, LLC, RA2022-3159042, Airo CT Scanner
Stryker informeert klanten van de Airo TruCT dat we bepaalde informatie uit de gebruikershandleiding van de Airo TruCT extra ...
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St. Jude Medical, FA-Q123-HF-1 Electronics System Emissions, CardioMEMS Patient and Hospital Electronics System
Abbott has identified that when the CardioMEMS Patient Electronics Systems (Models CM1000 and CM1100) and CardioMEMSTM Hospital ...
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Siemens Healthcare GmbH, CT083.22.S, SOMATOM go.diverse, x.cite.x.ceed, Naeotom Alpha
As a consequence, the head segment might mistakenly be labeled as “feet” and vice versa. If the wrong orientation labels are used ...
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Intuitive Surgical, Inc, ISIFA2022-09-C, SureForm 45.SureForm 45 Curved-Tip.SureForm 60
During standard post-market surveillance activities, Intuitive has observed an increase in complaints regarding engagement ...
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Siemens Healthcare Diagnostics Inc, DC 23-03, Dimension Tacrolimus Flex Reagent Cartridge
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with ...
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RAL Diagnostics, NC 23.012, MCDh 1
Trois signalements concordants ont été signalés sur ces lots de produits, des non-conformités internes ont été ouvertes et des ...
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Siemens Healthcare Diagnostics Inc, ACHC 23-01, Atellica CH LDL Cholesterol Direct DLDL reagents Total Protein II TP reagents Triglycerides Trig reagents Triglycerides_2 Trig_2 reagents
Siemens Healthcare Diagnostics Inc. has confirmed through customer complaints the potential for reagent carryover impacting ...