Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens Healthcare Diagnostics, ASW19-06, Atellica CH 930 Analyzer
Atellica® CH 930 Analyzer – Calibration Issue in Software versions 1.20.0 and below
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LivaNova USA, Inc., NM-HOU-2019-002 VNS Therapy® SenTiva® Generator
Unintended device disablement may occur in a small population of Model 1000 generators (Serial Numbers ≥ 100,000) due to a ...
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DIALAB, Diacon P 2019-09, Diacon P
The values for parameters Zine an Cooper of the package insert of the concerned lot of control show wrong data.
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Biomet Orthopedics ZFA 2019-00136 Various Biomet Products
A supplier who performs final cleaning operations on certain Zimmer Biomet products received an FDA Warning Letter earlier this ...
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Roche Diagnostics, CN-475505, HCYS
The calibration absorbance values were lower than expected.
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GCE s.r.o. 1000007695 MediEject II
When performing correlation measurements it has been identified that a number of MediEject Il display a deviation between actual ...
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Randox Laboratories Ltd REC422 NEFA
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 shows a positive shift in recovery for patient samples of approximately 10% ...
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GN Hearing A.S MS0028308 Resound, Beltone
GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which ...
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Convatec Limited 2019-006MA Convex Two-Piece Skin Barriers i.e. Natura
ConvaTec has voluntarily initiated a Field Safety Corrective Action in the form of a Customer Notification for specific product ...
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Maquet Cardiopulmonary GmbH FSCA-2019-09-11 Adult Small Adult VKMOs and VHK
During verification testing of Adult/Small Adult VKMOs and VHK a potential impairment of the sterile packaging barrier was ...