Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
240 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Abiomed Inc., 2023-FA-00156 / 2023-FA-00157, Impella CP Impella 5.5 Impella RP Impella 5.0
Abiomed discovered that information on safe use of lmpella pumps were issued with two technical bulletins (a.k.a. lmpella Product ...
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Fresenius Medical Care AG, SO-2024-0624, stay•safe Catheter Extension Luer-Lock variants
Fresenius Medical Care heeft door middel van tests vastgesteld dat niet-dioxineachtige polychloorbifenylzuren (PCBA's) kunnen ...
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CooperSurgical, Origio® Sperm Wash Medium
CooperSurgical has internally become aware of a non-conformity of Origo® Sperm Wash Media related to the low concentration of ...
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Medos International SARL, 2350411-Cerebase Guide Sheath Distal Cracking, CEREBASE DA Guide Sheath
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may ...
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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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GE Medical Systems SCS, FMI 32093, Care Plus & Lullaby incubators
GE HealthCare heeft ontdekt dat het bedpaneel van de Care Plus, Care Plus® Model 1000, 2000, 3000 en 4000 couveuses, de Lullaby ...
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BIRR Biosciences b.v, FSCA11012024, FBS Set
Helaas werd vastgesteld dat na deze période, 1 (van totaal van 3) zendingen met een ongeldige CE markering naar uw locatie is ...
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Atrium Medical Corporation, 3011175548-12/13/2023-002-C, Drains Express Single
On November 8, 2023, Getinge received notice from Nurse Assist, LLC that its Sterile Water, USP, 30mL syringes were being ...
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Siemens Healthcare GmbH, AX010/23/S (FSCA), AX038/23/S (FSN), Sensis
If the Sensis documentation functionality is used it may happen that during adding once-per-study reporting events (Type 1 ...
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KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever
It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...