Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
43 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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iMDsoft Ltd., MCR 151-2 MDSS ref. MDD23.144, MetaVision
Bij gebruik van het bestelsjabloon met de hoeveelheid in gewichtseenheden wordt de bestel-/dosishoeveelheid berekend volgens het ...
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Hamilton Bonaduz AG, FSCA-2023-01, CO-RE Tips CO-RE II Tips
As root cause the filter has been identified. Said filter is being inserted into to the tip during production.
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Boston Scientific Corporation, 97005302-FA, Watchdog Hemostasis Valve Kit
Boston Scientific is initiating a removal of specific batches of the WATCHDOGTM Hemostasis Valve Kit due to complaints of the ...
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Radiometer Medical ApS., FSN-FAN 915-424, AQURE system
AQURE System – possible incorrect reply on patient queries from LumiraDx device. Radiometer has become aware of a potential ...
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CooperSurgical tbd Sage Vitrification Media Kit
It has come to CooperSurgical’s attention that certain SAGE Vitrification Media Kits within LOT 211112-002333 may contain ...
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ALPRO MEDICAL GMBH, 3121, 3123, 3124, 3125-N, AlproCleaner
The product recall was decided after we discovered that AlproCleaner's delivery forms were shipped with incorrect labeling. As a ...
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FertiProNV, CAPA 2209-03, FertiCult Mineral Oil
FertiPro recently received a complaint of FertiCult Mineral Oil - lot FP21FM28 about decreased embryo development rate and ...
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FUJIFILM Irvine Scientific, Inc., FSN-RWN# 21001, Vitrification Freeze Kit
Dit herziene veiligheidsbulletin dient om aanvullende informatie te verstrekken over de Vitrification Freeze Kit:...
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B Medical Systems FSCA_2021001 - Premium Line devices with FW5.8
The customer reported that the temperature displayed by the unit was 3.9°C, while the actual air temperature inside the unit, ...
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Analis FSN 210707-1 - HyPro Medical 3 procent_v4_update
De prestatievalidatie is mislukt wat betreft de virucidale werking volgens EN14476 op het poliovirus.