Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
524 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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BALT EXTRUSION SAS, FSN-20210412_Silk Vista MRI Information Error, SILK VISTA
During the post-marketing surveillance program Balt Extrusion SAS received a customer complaint about an error in the MRI ...
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BALT EXTRUSION, FSN-20210224_SILKVista Baby_Missing Spring, SILK Vista Baby
In het kader van zijn programma van post-marketing surveillance heeft BALT Extrusion claims ontvangen betreffende de batch ...
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Maquet Cardiopulmonary GmbH, 997581, Cardiohelp-i
During service measurements in course of Field Action 881841 on the CARDIOHELP-i devices in the field, it was identified that the ...
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Maquet Cardiopulmonary GmbH, 782698, BS 3/8x3/32 L1.7
Since a label change in 2021, a label template with a Unique Device Identifier (UDI) was used for the type label attached to the ...
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B. Braun Melsungen, RECALL 2019-03-07 AS/LS, Certofix® Quattro
Omdat het defect niet kan worden beperkt, moet het hele Certofix Quattro-productaanbod worden teruggeroepen.
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Field Safety Notice: Bentley InnoMed GmbH, BeGraft Peripheral Plus Stent Graft System
In het kader van ons markt toezicht proces is opgemerkt dat tijdens het gebruik van de 7 en 8 mm items, volgens de etikettering 7 ...
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B.Braun Melsungen AG, FSCA-2023-08-21, Original Perfusor® Line
Tijdens onze post-market surveillance-activiteiten hebben we het risico vastgesteld dat luer-connectoren loskomen van de ...
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Gentherm Medical, LLC (formerly Cincinnati Sub-Zero), FSN-FA2021-003, UV Treo
Urgent Field Safety Notice UV Treo Advanced Temperature Management System.
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Maquet Cardiopulmonary GmbH, FSN-FSCA-2021-04-12, BE-HQV 52604 HLM Pack
Tubing set shipped prior to completion of degassing.
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Draeger Medical Systems, Inc., PR142097, Infinity Acute Care System .M540.
Draeger Medical Systems, Inc. (DMSI) has become aware during testing in conjunction with our global market surveillance ...