Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.589 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Maquet Cardiopulmonary GmbH, FSN-FSCA-2020-07-31, Heater Unit HU 35, ROTAFLOW System and ROTAFLOW System with ROTAFLOW ICU Console
Due to the update of the IEC Standard 60601-1-2 for Electromagnetic compatibility (EMC) to its 4th edition, the medical devices ...
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RaySearch Laboratories AB (publ), FSN-65340, RayCare 2C SP2, 3A SP1, 3B and 4A
This notice concerns an issue found in the Image viewer of RayCare PACS when visualizing a fusion with a study consisting of ...
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OTE Holding BV, FSN-FSCA290720NL, 042.001 Hydraclair ampoules
Hiermee willen we u informeren over de terugroepactie uit de distributieketen van de 042.001 Hydraclair ampullen (geclassificeerd ...
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B.BRAUN MEDICAL, FSN-NOCO2020-011, ACTREEN LITE CATH
B. Braun Medical have decided to proactively inform our customers in the context of a voluntary RECALL with regards to Actreen® ...
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AuXin Surgery s.a., FSN-NOCO2020-011, CADISS Kit
AuXin Surgery s.a. meldt Field safety over CADISS Kit
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Roche IO-0000167 (SB-CPS-2020-007) - Elecsys Anti-TPO assay
The internal documentation of the Elecsys Anti-TPO assay on cobas e 411, cobas e 601 and cobas e 602 platforms was checked as ...
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Siemens AX044_20_S - Sensis Vibe Hemo systems with MicroPod™ EtC02
We already informed you by our notification AX048/20/S about the MicroPod EtCO2 issue. Following this information, we inform you ...
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DiaSorin S.p.A FN-200731 - LIAISON® Measles lgM
DiaSorin S.p.a. internal testing confirmed, for the lot in object, a reduction of index value of samples. Such decrease could ...
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Elekta Ltd, FSN-FCA-EL-0011, Elekta Unity
Belangrijke veiligheidswaarschuwing Elekta Unity: Mogelijk verschil tussen beeld en omtrek tijdens bewegingsbewaking.
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Biosense Webster (Israel) Ltd., FSN-1821190, CARTO 3 System Version V7.1.80, CARTO VISITAG
Biosense Webster Inc. bewaakt continu de prestaties van haar producten om de veiligheid van de patiënt en de naleving van de ...